# tblAssets

Description:
Chatillon LF Plus Digital Tensile Machine


Description:
Thermometer 12-Ch & Thermocouple 0118-1 & 0118-2


Description:
Ionizing Air Gun Hapa-Filtered (0.01micron)


Description:
Pulse Bar Ionizing Bar W/ PulseFlow Controller


Description:
Mini Torque wrench, fixed set, range 0.7-32oz/in


Description:
Collimator ("MTF") With Resolution and crossed-sli


# tblCAPA

Description:
Software verification written in internal memo format


Description:
Smudge and in completed print on the labels


Description:
During clinical lot release testing tangled lens were observed at the final unfolding phase during injection

Investigation:
Lens loading angle influences the rate of tangling. Evaluated lens loading angle at several angels, determine that 17.5° are the best with out tangle lens.

Action:
Lens loading fixture for assembly has been change


Investigation:
An exact cause not determined, re training to cleanliness practices in production area.


Description:
During clinical evaluation of the synchrony lens & injector, fibers were observed in the eye after surgery

Investigation:
Fiber from the clean room are getting in to the injector during assembly.


Description:
During review of several clinical cases, complaint were not documented in the complaint handling system

Investigation:
Information from clinical cases were not communicated to QA

Action:
On going communication between clinical and QA, also revised SOP and WI


Description:
Scratch , tear, and nick observed on lens during lot release testing.

Investigation:
Root cause were from rail flash on the nozzle


Description:
In-house generated label smear and smudge (random)

Action:
Label stock has been change to improve process


Description:
Excessive molding defects from suppliers (injector)

Action:
Implemented rework procedure for in coming inspection


Description:
Steak mark (grease) observed on the nozzle

Investigation:
Burnt resin deposited by the ejector pin


Description:
During lot release testing lens# 14 was tangled after injection

Investigation:
Cover were assembled too tightly to the base and or interference could occur due to assembly stack-up between the new alignment rib and the slide


Description:
No Specific callout exist on base and cover drawing that address (EPM)

Investigation:
Embedded particulate allowance note not in the drawing

Action:
Drawing has been revise for clarification


Description:
NCR's and associated C/A exceed duration time as specified in SOP

Investigation:
tooling/molding process at the vendor and proprietary process of coating suppler require extended time to investigate root cause and obtain C/A.


Investigation:
The supplier final inspection set-up did not have capability to screen out partially coated slide.


Investigation:
Condition of tool produce the cover with rib feature that is larger then the drawing Spec.


Description:
Confluent Growth reported on air sampling results

Investigation:
Ceiling and walls (including upper walls surface) had not formally been wiped down

Action:
A full wipe down of the clean room was performed, also now on a regular schedule monthly basis


Investigation:
Mistake on 625-002 slide mold, mistake caused target dimension to be off

Action:
Mold has been corrected and the drawing will be updated


Description:
Coated Slide and nozzle did not pass functional test

Investigation:
The failure was relate to the coated slide. Uneven coating and very thin coating were observed on the slide.

Action:
1-Retested the nozzle w/accept. Slide & released. 2-Slide coating issues were communicated to Hydiomer on 06/28/06


Description:
Lens Surface Defects Analysis of surface Defects, Dimple & Fiber/Particulate which are the top  3 Defects (molding process)

Investigation:
1-Durty lens stick to the smooth surface of the beaker 2-


Description:
Functional test -Lens injector displacement is somewhat tight or stuck and fold can stick or cannot fold

Investigation:
Base and cover mismatch on Arbor press and cleaning method

Action:
Revised cleaning method and implement PM schedule for Arbor press Gap Distance.


Description:
Coated Slide-Partial Coating in channel curl

Action:
Supplier has submitted C/A and continue to be inspected, tested and monitored


Description:
lens injector unit have exhibited tight fit, stuck during folding and in one case tangled lens, ( the tangled lens was untangled during the clinical procedure)

Action:
Revised arbor press setup parameter to .907" ±0.001"


Description:
Document 250-003 not clear on accept and reject

Investigation:
Word & terminology used in 250-003 Rev.D section 6.3.8.1.3 needs to be standardize and clearer in order to clarify accept & reject condition of the lens.


Description:
Slide drawing (625-002) to be revised to include added cal/out for visual inspection of rail & channel feature.

Investigation:
Drawing does not have specific inspection requirement of the rail and channel feature of the slide.

Action:
Revise drawing to specify visual inspection of the rail & channel feature.


Description:
The post-sterile lens cosmetic Spec. not clear

Investigation:
Visogen was still in the development stage. (Ref. to PO-017 for C/A)


Description:
Drawing for molded component does not depict the gate remnant. Parts were rejected for over size gate.

Investigation:
The drawing to be updated to show the gate remnant since the part will now exhibit this feature during incoming receiving inspection.


Description:
During NSAI Audit ACM (cleanroom cleaning service) not list on the approve vendor list.

Investigation:
Visiogen did not assign a responsible party to ensure that the cleanroom service was being received on a periodic base. Add & added to vendor list.


Investigation:
High friction between moving nozzle and slide components cause by IPA cleaning of polycarbonate material.


Description:
Slide Dimensional @ .600 are not compatible with lens placement operation

Investigation:
Molded at nominal @ .600 not compatibles, compared to slide that are .597-.598

Action:
The slide length been optimized based on test results and a tolerance analysis. First article molded slide received from Kuico made to the updated slide length specification were received by Visiogen, tested, and have been accepted. All actions required o


Description:
Increase in incident rate of "static member stuck and lens tangled" during use.


Description:
Increase in incident report from the filed of tangled lens during implantation.


Description:
Preventive Maintenance of Movit not perform as indicated in R04-022 since 2003/2004

Investigation:
The Preventive Maintenance instructions were attached to and within the test report R04-022.The PM instructions were not forward to the PM system

Action:
Attached PM form-005 and intervals frequency was specified


Investigation:
Mold Fabrication process yielded an insert undersize for optic center thickness. Other five mold in the batch were acceptable for this feature


Description:
Nozzle, coating "missing" coating # 22, lens Tear

Investigation:
During functional test for coating lot release, Work order # 08080E nozzle, coating; # 22 missing in the channel. Lens # 22 tear posterior spring


Description:
Mixed coating appears clear and has small white particulates

Investigation:
root cause is crosslinker B react w/ moisture in ambient conditions of storage.


Investigation:
This CAPA was initiated to further investigation a specific aspect  initiated under NCR 08-012. Visiogen Sterilization lot 08114A showed incidences of diopter measurement discrepancy larger then allowed per specification between the pre-sterile in-process


Investigation:
The investigation into the root cause of the lens discolored and failure mitigation has not been completed as of yet


Description:
No System in place to review External Standard upon revision

Investigation:
External Standards procedure did not include the review portion

Action:
Updated procedure to add a review proceess and a new form-138 to document the process WI-021


Description:
Lens mold, made from Raw material-ULTEM Cracking during lens mold process


Description:
LAL test samples were not pulled for post-sterile

Investigation:
The test sample were not prepared during production builds.


Description:
Not all suppliers being used at Visiogen is on the approve supplier list

Investigation:
Due to the nature of the procedure, several suppliers lacking the appropriate documentation have been removed from the approved supplier list


Description:
Additional PM activity is needed to develop PM schedules


Description:
Viscosity Spec. from supplier and internal Spec. on the Form-061 did not match

Investigation:
Review of incoming inspection files shows that several lots of silicone Med 6-6820 part A (were acceptated even though the supplier viscosity spec. was outside of visiogen spec. on the form.


Investigation:
It has been determined that Crossliker B is sensitive to moisture as seen in CAPA08-003 a review of historical records both in MFG. and R&D shown no other issue or sensitive.


Investigation:
Eyesupply are not in approve supplier list

Action:
Perform and online assessment of EyeSupply, and write a memo to explain the use of BSS and reason for not adding EyeSupply to the approved supplier list.


Description:
Not all supplier have been assessed to Rev. E of WI-006

Action:
Complete FORM-021 revision D for suppliers who were assessed prior to the current revision.  Write up memo to explain why the current FORM-021 was completed for those suppliers assessed prior to the current revision instead of waiting unti lthe next evalu


Description:
Training procedure (SOP-010) has been revised and will be released prior to the implementation of the training database and matrices.

Investigation:
Several external audits have identified training as an area needing improvement

Action:
Finalize training matrices for each job description, implement database and import training information, and write up a memo to explain the process and historical records.


Description:
No Procedure for Subassembly and final assembly. Possible lens mix-up

Investigation:
Work orders did not have operation sequence that handle non-conforming lens and conforming lens separately


Description:
Bioburden at Rodac plate @ location 8 too high

Investigation:
The area in question may not have been adequately cleaned due to the sealer position in the area


Description:
Viscosity out of supplies Spec. and work time hours S/B 3-5 is 5-7 hours

Action:
Summary of testing, which includes extraction & qualification test. Report# R02-036


Description:
Lens inner diameter U/S for insert mold / top (#5)

Investigation:
Mold is acceptable. The tolerance will be revised to allow a smaller diameter. No affect to fit w/ interfacing mold


Description:
Diameter .250 has presence of fibrous material

Investigation:
Tool used to cut the hole was not sharp enough causing rough finish around the rim of hole.


Investigation:
Lens accountability during tumbling lead to mix-up of work order


Description:
Dye penetrate test, 3 out of 21 penetration greater then 20% of seal width in supplier seal..

Investigation:
Possible cause is suppliers MFG. process or stretching of the seals

Action:
Retest of the outer pouch and inner pouch results indicates that vendor seal strength lower then in-house. Revised procedure DCO # 0219


Description:
Lens post inspection-compromised post is an attribute that is difficult to inspect and detect

Investigation:
During removal of lens from the mold, cause can be attributed to the mold (pin hole) and the technique of removing the lens by the operator.


Description:
Incorrect sample size per ECH calculation, results in greater than 25 ppm

Investigation:
The lab used the mathematical formula using 3 lens to calculate a theoretical limit of 26ppm is limit per ISO 10993. change to 4 lens will bring mathematical limit to 20.0ppm which is desired to be lower then 25ppm


Description:
Increasing variation of seal strength, results indicate a shift towards reduced process control

Investigation:
The pouch are an off the-shelf product, supplier seal strength results are typically lower then in-house seal.


Investigation:
off the shelf pouch MFG. for general Laboratory use

Action:
UAI-will be use for testing and clinical


Investigation:
Core pin move during injection molding cycle.


Investigation:
Mold did not close completely during molding cycle.

Action:
Mold has been adjusted to gave correct Spec.


# tblCompanys

ServiceType:
EO sterilization process challenge device


# tblDCO

Notes:
CANCELED BY EVERETT SUPERCEDED BY DCO# 0066


Notes:
TITLE FOR R02-002 IS "ETO STERILIZATION TRRIAL RUN OF THE VAIOL AND BIOCOMPATIBILITY TEST OF THE ULTEM LENS CASES.


Notes:
DEVIATION - WIP IS REPROCESS - EFFECTIVITY IS 6/25/02 TO 9/30/02


Notes:
DEVIATION                                            DEVIATION WAS CLOSED ON 12/04/02                                                THIS DEVIATION WAS USED FOR LOT # 4202288A, 4302295A, 4402302B, 4502308B, 4302295B, 4402302A


Notes:
DEVIATION                                            START - 12/16/02  STOP - 01/30/02


Notes:
Other: Hai Min Pham                             Date: 04/18/03


Notes:
CANCEL ALL PART NUMBERS IN THIS DCO. PER TUAN NGUYEN 5/31/06     NEW PART NUMBERS WERE ISSUED.


Notes:
Title: Mixing and Storing of Hydrophillic Coating Material for Coating of Injector Components


Notes:
Wilfred Medel  08/02/06                     OTHER: Ed Balcos  08/02/06


Notes:
R.A.: PENNY FRABOTTA FOR BARBARA NIKSCH PER CONVERSATION  08/03/06


Notes:
500-010 MATERIAL DISPOSITION IS FOR 625-014(BASE) & 625-005(COVER)


Notes:
R.A.: ED BALCOS FOR EVERETT LOVE  DATE: 03/16/07


Notes:
R.A. / DATE: ED BALCOS FOR EVERETT LOVE  03/28/2007


Notes:
OBSOLETE: FORM-081, FORM-078, FORM-080, FORM-082, FORM-019


Notes:
On hold per James Oh & Joe Paz  10/08/2007                  Off Hold on 1/23/08


Notes:
MANFG. ENGR. / DATE: W. MEDEL  01/24/2008


Notes:
OTHER / DATE:  Katrina Dayman / 01/25/2008        DEVIATION


Notes:
OTHER / DATE:  Katrina Dayman / 01/23/2008


Notes:
MANFG. ENGR. / DATE: Wilfred Medel / 01/25/2008                                        RELIABILITY / DATE: Katrina Dayman / 01/24/2008


Notes:
CANCELED PER JAMES OH      SEE DCO #0827


Notes:
OTHER / DATE: Med Harbin / 02/15/2008                                        OBSOLETE DOCUMENTS


Notes:
OTHER / DATE:  Katrina Dayman / 02/15/2008


Notes:
MFG. ENG. / DATE: Wilfred Medel / 03/10/2008


Notes:
MFG. / DATE:  Wilfred Medel / 03/11/2008                                           R&D / DATE:  Tuan Nguyen / 03/11/2008


Notes:
R&D / DATE: Scott Evans / 03/5/2008  RELIABILITY ENGINEERING / DATE: Katrina Dayman / 02/25/2008


Notes:
Put on hold for 1-1/2 months. Wasn't sure if it was going to be a new class code category.


Notes:
700-132, FORM-117 & FORM-118 ARE OBSOLETE


Notes:
OTHER / DATE: Katrina Dayman / 4/30/2008


Notes:
OTHER / DATE: Katrina Dayman / 05/14/2008


Notes:
OTHER / DATE: Katrina Dayman / 5/14/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 5/28/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 5/30/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 6/2/2008


Notes:
RELIABLITY / DATE: Katrina Dayman / 06/02/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 06/03/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 06/06/2008                                       OTHER / DATE: Albert Ting / 06/05/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 06/05/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 06/06/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 06/23/2008      OTHER / DATE: Renee Van Dorne / 06/30/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 06/19/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 06/02/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 06/27/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 06/26/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 06/12/2008    OTHER / DATE: Renee Van Dorne / 6/30/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 06/30/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 7/11/08


Notes:
RELIABILITY / DATE: Katrina Dayman / 07/10/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 07/18/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 07/22/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 07/16/2008                                         OTHER / DATE: Albert Ting / 07/14/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 07/28/2008


Notes:
RELIABILITY / DATE: Katrina Dayman / 07/14/2008


Notes:
RELIABILITY / DATE: Jennifer Hansen / 07/29/2008


Notes:
Q.A./Q.E./Date:                                     Renee Van Dorne/07/30/08                  Reliability/Date:                                     Katrina Dayman/07/30/08                    Other/Date:                                          Renee Van Dorne/07/30/08


Notes:
Reliability/Date:                                Jennifer Hansen/10/10/08                  Other/Date:                                        Pat Stewart/11/7/08 Due to lack of signature, could not remember when signed


Notes:
Reliability/Date:                              Jennifer Hansen/10/29/08                Other/Date:                                     Reza Zadno/11/25/08


Notes:
Reliability/Date:                             Jennifer Hansen/10/30/08                 Other/Date:                                        Reza Zadno/10/16/08


Notes:
Reliability/Date:                                Renee Van Dorne/11/20/08              Other/Date:                                         Reza Zadno/11/20/08


Notes:
Reliability/Date:                                Jennifer Hansen/11/12/08                 MFG.ENG./Date:                                    Duc Tran/12/05/08


Notes:
Reliability/Date:                               Jennifer Hansen/12/05/08                   Other/Date:                                         Phu Nguyen/12/05/08


Notes:
Reliability/Date:                                   Jennifer Hansen/12/11/08                  Other/Date:                                          Tuan Nguyen/12/12/08


# tblDCODetail

Description:
Performance Evaluation of the VIOL System


Description:
Performance Evaluation of the VAIOL System


Description:
MIXING,DEGASSING & STORING OF SILICONE MATERIAL


Description:
ENVIRONMENTAL MONITORING OF PRODUCT AND CEA AREA


Description:
CLEANROOM REQUIREMENTS, RESTRICTIONS & GUIDELINES


Description:
EVALUATION OF MANUFACTURING AND FACILITY EQUIPMENT


Description:
FABRICATION OF VISIOGEN ACCOMODATING IOL (VAIOL)


Description:
AIOL OPTICAL CONSIDERATION-EYE MODEL EVALUATION


Description:
OPTICAL CONSIDERATIONS OF DUAL IOL INSPECTION


Description:
TESTING OF OPTIC TILT AND DECENTRATION OF THE VAIO


Description:
DEVICE HISTORY RECORDS AND PRODUCT RELEASE


Description:
CLEANING AND DISINFECTING OF RETURNED LENSES


Description:
AXIAL DISPMT. IN RADIAL CMPRSN. TEST OF THE VAIOL


Description:
6 MNTH. ACLRTD. SHLF. LIFE STUDY FOR LBLNG. OF CL


Description:
TESTING OF OPTIC TILT & DECENTRATION OF THE VAIOL


Description:
TESTING OF FATIGUE DURABILITY OF THE VAIOL


Description:
EXTRACTION AND VACUUM DRYING OPERATION RECORD


Description:
SPECTRAL TRANSMITTANCE TEST OF THE VAIOL


Description:
FINAL CLEANING AND PACKAGING OF THE VAIOL


Description:
ASSESSMENT OF A NEW ACCOMMODATING IOL IN RABBIT EY


Description:
AXIAL DSPLCMNT. IN RADIAL CMPRSN. TEST OF THE VAIO


Description:
ETO STERILIZATION TRIAL RUN OF THE VAIOL & BIOCOPA


Description:
CE MRKD PRDCT-CLSFCTN & CNFRMTY ASSESSMNT PROCEDRE


Description:
CONFORMITY ASSESSMENT PROCEDURE FOR MEDICAL DEVICE


Description:
CLASSIFICATION OF THE MEDICAL DEVICES & ACCESSORIE


Description:
ACCOMMODATING IOL DESIGN AND DEVELOPMENT PLAN


Description:
STERILITY& ETO RSDL TESTS OF THE PLYCRBNT LENS CAS


Description:
1 YEAR ACCLRTD SHELF LIFE STDY FOR LBLNG OF CLN UN


Description:
CADAVER EYE IMPLANTATION STUDY OF THE VAIOL


Description:
LABEL, FOR INVESTIGATIONAL USE ONLY, CLEAR


Description:
ETHYLENE OXIDE DISSIPATION CURVES STUDY OF VAIOL


Description:
CYTOTOXICITY TEST OF THE IN-HOUSE VISIOGEN ULTEM 1


Description:
MIXING, DEGASSING & STORING OF SILICONE MATERIAL F


Description:
MEDICAL DEVICE VIGILANCE SYSTEM PROCEDURE


Description:
REPORT OF THE CYTOTOXICITY TESTS OF THE IN-HOUSE &


Description:
EXTRACTION & VACUUM DRYING OPERATION RECORD


Description:
ULTEM 1000 VISIOGEN MOLDS & INSERTS FAB. PROCESS


Description:
RPT. OF IQ & OQ FOR THE SERVO IMPACT 2 CNC MILLING


Description:
I.Q. AND O.Q. FOR THE SERVO IMPACT 2 CNC MILLING M


Description:
DESIGN OF EXPERIMENT (DOE) - TUMBLING PROCESS


Description:
AXIAL COMPRESSION FORCE DATA RECORDING SHEET


Description:
MIXING, DEGASSING & STORING OF SILICONE MAT. FOR F


Description:
SYNC-503-IOL - FEASIBILITY INVESTIGATIONAL PLAN


Description:
ENGINEERING BIOCOMPATIBILITY TESTS OF THE VAIOL


Description:
TESTING OF MATERIAL MED-6820, LOT# 25898


Description:
ULTEM 1000 VISIOGEN MOLDS AND INSERTS FABRICATION


Description:
FEASIBILITY STUDY, SYNC-505-IOL, INVESTIGATIONAL P


Description:
I.Q., O.Q. AND OPTICAL PERF. QUAL.. OF THE MOVIT


Description:
ENVIRONMENTAL MONITORING OF PRODUCT & CEA AREA


Description:
MOLD, BOTTOM, 19-24.5 DIOPTER (R&D 9-14)


Description:
MOLD, MIDDLE, 19-24.5 DIOPTER (R&D 9-14)


Description:
PREVENTIVE MAINTENANCE PROCEDURE FOR MOLD CLAMPS


Description:
PREVENTIVE MAINTENANCE LOG FOR MOLD CLAMPS


Description:
1 YEAR CLINICAL UNIT ACCELERATED SHELF LIFE STUDY


Description:
RPRT OF INSTLN, OPRTNL & OPTCL PERFMNC OF THEMOVIT


Description:
MOVIT FOCAL LENGTH VERIFICATION DATA SHEET


Description:
OPTICAL INSPTN PROCEDR OF THE VAIOL ON THE MOVIT


Description:
MOLD, BOTTOM, R&D9-20, 28-31, 33-34, INSPT. DRAWIN


Description:
MOLD, MIDDLE(INSERT), R&D9-20, 28-31, 33-34, INSPT


Description:
MOLD, TOP, R&D9-20, 28-31, 33-34, INSPT. DRAWING


Description:
VAL. OF FATIGUE TESTER FOR LONG TERM DYN. FAT. TES


Description:
LONG TERM DYNAMIC FATIGUE TESTING OF THE VAIOL


Description:
PROCEDURE, DIMENSIONAL INSPECTION OF VAIOL


Description:
RECVNG, INSPCTN AND TESTING OF SILICONE RAW MATERL


Description:
OPTICAL INSPECTION PRCDR OF THE VAIOL ON THE MOVIT


Description:
MOLD, BOTTOM 16.0-18.5D, INSPECTION DRAWING


Description:
MOLD, MIDDLE(INSERT) 16.0-18.5D, INSPECTION DRW.


Description:
MOLD FIRST ARTICLE INSPECTION AND RELEASE


Description:
PRCSS FAILURE MODE & EFFCT ANLYSS RPRT OFTHE VAIOL


Description:
SYNC-506-IOL INVESTIGATIONAL PLAN - BELFORT


Description:
SYNC-507-IOL INVESTIGATIONAL PLAN - TRINADADE


Description:
PROCEDURE FOR USING ACCEPTANCE SAMPLING PLAN


Description:
VLDTN OF FTGUE TSTR 4 LNG TRM DYNMC TSTNG OF VAIOL


Description:
VISIOGEN SYNCHRONY LENS FINAL CLEANING VALIDATION


Description:
QUALIFICATION OF NITRILE GLOVES IN SYCHRONY MANF.


Description:
2-YR/3-YR ACCLRTD SHLF LIFE STDY FOR LABELING OF C


Description:
SYNCHRONY INJECTOR PRODUCT REQUIREMENTS DOCUMENT


Description:
TEST REPORT-UVINUL 3060 RAW MATERIAL TEST


Description:
PERFORMANCE EVALUATION OF THE VISIOGEN INJCTR SYSM


Description:
STUDYING THE RELATIONSHIP & INTERACTION BETWEEN TH


Description:
TUMBLE POLISHING PROCESS FOR LENS CARRIER


Description:
QUALFTN OF NITRILE GLOVES IN SYNCHRNY MAN. PROCES


Description:
TEST REPORT - POUCH SEALER PROCESS QUALIFICATION


Description:
MOLDING PROCESS QUALIFICATION FOR SYNCHRONY LENS


Description:
MOLD, MIDDLE(58000), 19.0-24.5D, V9, INSPECTIN DRW


Description:
MOLD, TOP(58000), 19.0-24.5D, V9, INSPECTIN DRW


Description:
MOLD, BOTTOM(58000), 19.0-24.5D, V9, INSPECTIN DRW


Description:
MOLD, BOTTOM, 16.0-18.5D, R&D 35-40, INSPECTIN DRW


Description:
MOLD, MIDDLE(INSRT, 25.0-28.0D,R&D35-40 INSPT. DRW


Description:
MOLD, BOTTOM, 25.0-28.0D, R&D 21-27, INSPCTN DRW


Description:
MOLD, MIDDLE(INSRT, 25.0-28.0D,R&D21-27 INSPT. DRW


Description:
MOLD, TOP, 25.0-28.0D, R&D21-27 (INSPECTION DRWNG)


Description:
MOLD, BOTTOM, 19.0-24.5D, R&D 3-8, INSPCTN DRW


Description:
MOLD, MIDDLE(INSRT), 19.0-24.0D,R&D3-8 INSPT. DRWN


Description:
MOLD, TOP, 19.0-24.0D, R&D 3-8 (INSPECTION DRWNG)


Description:
MOLD, BOTTOM, 19.0-24.5D, INSPECTION DRWNG.


Description:
MOLD, MIDDLE(INSRT), 19.0-24.5D, INSPECTION DRWNG.


Description:
COSMETIC INSPECTION CRITERIA OF VISIOGEN AIOL


Description:
LENS POST FUNCTIONAL TEST & 2X ETO STUDY


Description:
VISIOGEN SYNCHRONY LENS EXTRACTION & DRYING VALIDA


Description:
SILICONE MIXING PROCESS QUALIFICATION REPORT


Description:
SYNC-509 IOL - FEASIBILITY INVESTIGATIONAL PLAN


Description:
TUMBLING POLISHING PROCESS QUALIFICATION REPORT


Description:
VISIOGEN AIOL COMPRESSION FORCE DECAY TEST VALIDAT


Description:
MECHANICAL TESTS OF THE VISIOGEN SYNCHRONY LENSES


Description:
VAIOL AXIAL & RADIAL COMPRESSION FORCE TEST VALIDA


Description:
VALIDATION OF VAIOL OPTIC TILT & DECENTRATION TEST


Description:
VALIDATION OF VAIOL AXIAL DISPLACEMENT TEST


Description:
REPORT OF THE VALIDATION OF THE VAIOL FOLDING TEST


Description:
VALIDATION OF THE VAIOL OPTIC TILT & DECENTRATION


Description:
DESIGN QUALFCTN TESTS FOR THE NEW DESGN OF SYNCHRO


Description:
LENS LOCATION IN FATIGUE TEST-RECORDING SHEET


Description:
DYNAMIC FATIGUE TESTING PROCEDURE OF THE VAIOL


Description:
MOLD, BOTTOM (19.0-24.5D) V10, INSP. DRW.


Description:
MOLD, MIDDLE(INSERT), V10 (19.0-24.5D), INSP. DRW


Description:
BIOCOMPATIBILITY TESTS OF THE VISIOGEN SYNCHRONY L


Description:
VALIDATION OF THE VAIOLCOMPRESSION FORCE DECAY TES


Description:
SYCHRONY INVESTIGATIONAL PLAN SYNC-508 IOL


Description:
MOLD, BOTTOM (19.0-28.0D) V10, INSPECTION DRAWING


Description:
MOLD, MIDDLE (INSRT) (19.0-28.0D) V10, INSPT. DRW.


Description:
RPT. OF BIOCOMPATIBILITY TESTS OF THE VAIOL SYCHRO


Description:
AXIAL DISPLACEMENT IN RADIAL COMPRESSION TESTS OF


Description:
MOLD, BOTTOM (16.0-28.0D), V10, INSPECT. DRAWING


Description:
MOLD, MIDDLE(INSERT), (16.0-28.0D) V10, INSPT. DRW


Description:
MECHANICAL TESTS OF THE VISIOGEN SYNCHRONY LENS


Description:
VALIDATION OF THE VAIOL AXIAL & RADIAL COMPRESSION


Description:
INJECTOR COMPONENT CLEANING PROCESS IMPROVEMENT


Description:
CLEANING PROCEDURE FOR LENS CARRIER PARTS


Description:
SYNCHRONY INJECTOR ASSY. PROCESS FAILU MODE (FMEA)


Description:
IMPLANTATION OF A DUAL OPTIC IOL W/A NEW INJECTOR


Description:
REPORT OF CLEANING PROCESS QUALIFICATION PROTOCOL


Description:
INJECTOR COMP. CLEANING PROCESS IMPROVEMENT QUALIF


Description:
CLEANING PROCEDURE FOR SYNCHRONY INJECTOR PARTS


Description:
BIOCOMPATIBILITY TESTS FOR SYNCHRONY IOL IN POLYPR


Description:
SHIPPING TEST OF THE VISIOGEN PACKED SYNCHRONY LEN


Description:
LENS INJECTOR, FINAL ASSY, 16.0-24.5D, GENERIC


Description:
FINAL INSPECTION OF LENS INJECTOR ASSEMBLY


Description:
CLEANING PROC.FOR SYNC. INJECTOR NOZZLE & SLIDE CO


Description:
1-YEAR ACCLRATD SHELF LIFE STUDY FOR LENS PKGD W/P


Description:
LENS INJECTOR, FINAL ASSY., 16.0-24.5D, GENERIC


Description:
LABEL, OUTER POUCH(CARRIER), PETG TRAY(INJECTOR)


Description:
PICK LIST GENERATION PROCEDURE, VERIFICATION


Description:
PICK LIST GENEREATION PROCEDURE, VERIFICATION


Description:
OUS CLINICAL I INJECTOR LOT RELEASE PROTOCOL


Description:
SYNCHRONY INJECTOR ASSEMBLY PROCESS (MOA) MAN. OPE


Description:
ENVIRNMENTAL MONITORING OF PRODUCT & CEA AREA


Description:
VALIDATION OF SOFTWARE & COMPUTER BASED SYSTEMS


Description:
SOFTWARE & COMPUTER BASED SYSTEM RISK ANALYSIS


Description:
LENS INJECTOR, FINAL ASSY.,16.0-24.5D, GENERIC


Description:
OUS CLINICAL 1 INJECTOR LOT RELEASE-TEST REPORT


Description:
MOLD, TOP, V11, (16.0-28.0D) INSPECTION DRAWING


Description:
MOLD, BOTTOM, V11, (16.0-28.0D) INSPECTION DRAWING


Description:
MOLD, MIDDLE(INSERT), V11, (16.0-28-0D) INSPT. DRW


Description:
VALIDATION OF THE VAIOL AXIAL DISPLACEMENT TEST


Description:
DYNAMIC RESPONSE TIME OF VISIOGEN SYNCHRONY LENSES


Description:
OPTICAL INSPCTN PROCDRE OF THE VAIOL ON THE MOVIT


Description:
DESIGN QUALIFICATION TESTS FOR THE VAIOL


Description:
VISIOGEN SYCHRONY LENS EXTRACTION & DRYING VALIDAT


Description:
MOLD, BOTTOM, INSP. DRW., (16.0-28.0D), V11B


Description:
MOLD, MIDDLE(INSERT), INSP. DRW. (16.0-28.0D),V11B


Description:
DYNAMIC RESPONSE TIME OF SYNCHRONY LENS - REPORT


Description:
MTF INSPCTN VALIDATION & MTF MEAS. OF THE VISIOGEN


Description:
OPTICAL TESTS OF THE VISIOGEN SYCHRONY LENSES


Description:
POST STERILE INSPECTIONS OF VISIOGEN AIOL


Description:
PRODUCT SPEC., VISIOGEN SYNCHRONY LENS, VERSION 10


Description:
MTF INSPECTION VALD. & MTF MEASUMENT. OF THE VAIOL


Description:
AXIAL DSPLCMNT IN RADIAL CMPRSSN TEST OF THE VAIOL


Description:
DESIGN QUALIFICATION TESTS FOR THE VAIOL VER. 11


Description:
LENS, FINAL ASSEMBLY, R&D 23-V12 (26.0D)


Description:
LENS, FINAL ASSEMBLY, R&D 21-V12 (25.5D)


Description:
LENS, FINAL ASSEMBLY, R&D 21-V12 (25.0D)


Description:
LENS, FINAL ASSEMBLY, R&D 34-V12 (24.5D)


Description:
LENS, FINAL ASSEMBLY, R&D 33-V12 (23.5D)


Description:
LENS, FINAL ASSEMBLY, R&D 28-V12 (22.5D)


Description:
LENS, FINAL ASSEMBLY, R&D 31-V12 (21.5D)


Description:
LENS, FINAL ASSEMBLY, R&D 30-V12 (20.5D)


Description:
LENS, FINAL ASSEMBLY, R&D 29-V12 (19.5D)


Description:
LENS, FINAL ASSEMBLY, R&D 16-V12 (24.0D)


Description:
LENS, FINAL ASSEMBLY, R&D 15-V12 (23.0D)


Description:
LENS, FINAL ASSEMBLY, R&D 20-V12 (22.0D)


Description:
LENS, FINAL ASSEMBLY, R&D 19-V12 (21.0D)


Description:
LENS, FINAL ASSEMBLY, R&D 18-V12 (20.0D)


Description:
MOLD, TOP, 16.0-28.0D, V10, INSPECTION DRAWING


Description:
MOLD, BOTTOM, 16.0-28.0D, V10, INSPECTION DRAWING


Description:
MOLD, MIDDLE (INSERT), 16.0-28.0D, V10, INSP. DRW.


Description:
DESIGN QUALIFICATIN TESTS FOR THE VAIOL VERSION 12


Description:
VALIDATION OF ETHYLENE OXIDE STERILIZATION PROCESS


Description:
MOLD, BOTTOM, 16.0-28.0D, V12, INSPECTION DRAWING


Description:
MOLD, BOTTOM, 16.0-28.0D, V11, INSPECTION DRAWING


Description:
DEVICE HISTORY RECORDS & PRODUCT RELEASE


Description:
PALLETIZATION FOR STERILIZATION, LENSES, PARTER ME


Description:
OPTICAL INSPN. PROCEDURE OF THE VAIOL ON THE MOVIT


Description:
SHIPPING TESTS OF THE VISIOGEN PACKAGED SYNCHRONY


Description:
PRODUCT SPEC., VISIOGEN SYNCHRONY LENS VER. 12


Description:
PRODUCT SPEC., VISIOGEN SYNCRONY LENS VER. 11


Description:
INSTLTN. & OPRTNL. QUAL. OF THE MD-1612 LAB. SEALR


Description:
SHIPPING TESTS OF THE VISIOGEN PKGD. SYNCHRONY LEN


Description:
MTF MEASRMNT. OF THE VAIOL IN NEAR, INTER. & FAR P


Description:
TEMP. & HUMIDITY EXPSR. OF THE INJCTR. SLID. & NZL


Description:
2-3 YEAR ACCELERATED SHELF LIFE STUDY FOR LABELING


Description:
FUNCTNL. EVALUTN. OF SYNCHRONY INJTR. W/SYNC. LENS


Description:
DVLPMNT. & VRFCTN. OF "IOL CONVERSION2 TEST.XLS" P


Description:
INSTLLTN & OPRTNL. QUAL. OF THE MD-1612 LAB. SEALR


Description:
SHIPPING TEST OF THE VISIOGEN PCKGD. SYCHRONY LENS


Description:
TFR MSRMNT. OF THE VISIOGEN LENS IN THE NEAR POSIT


Description:
WEIGHT OF THE VISIOGEN LENS IN AIR AND IN WATER


Description:
INSTAL. AND OPER. QUAL. OF THE OGP SMARTSCOPE


Description:
SELECTION AND QUALIFICATION OF INVESTIGATORS AND


Description:
SYNCHRONY INJECTOR DESIGN VERIFICATION PROTOCOL


Description:
PERFORMANCE AND PROCESS QUALIFICATIONS FOR MD-1612


Description:
REPEATABILITY AND REPRODUCIBILITY STUDY OF MOVIT


Description:
QUALIFICATION OF THE BRANSON ULTRASONIC CLEANER


Description:
EVALUATION OF SYNCHRONY INJECTOR W/ SYNCHRONY LENS


Description:
TEST OF COMPRESSION SET OF SYNCHRONY LENS


Description:
GENERIC LENS-INJECTOR, FINAL ASSEMBLY, VII


Description:
CLEANING AND PACKAGING OF VISIOGEN INTRAOCULAR LEN


Description:
INJECTOR FOLDING EVALUATION OF VISIOGEN LENS


Description:
MOLD-TOP (16.0 - 28.0D) VII INSPECTION DRAWING


Description:
MOLD-BOTTOM (16.0 - 28.0D) VII INSPECTION DRAWING


Description:
MOLD -MIDDLE (INSERT) 16.0 - 28.0D VII INSPECTION


Description:
INSTAL. AND OPER QUAL. OF BRANSON ULTRASONIC CLEAN


Description:
CLINICAL PROCEDURE: CLINICAL STUDY SITE MONITORING


Description:
OPTICAL INSPEC PROCED OF THE VISIOGEN INTRAOCULAR


Description:
BIOCOMPATIBILITY TESTS FOR THE VISIOGEN SYNCHRONY


Description:
MOLD-MIDDLE (INSERT) V14 19.0-24.5D INSPECTION


Description:
MOLD-TOP, V14, 16.0-28.0D, INSPECTION DRAWING


Description:
MOLD-MIDDLE (INSERT) V14 16.0-18.5D INSPECTION


Description:
MOLD-BOTTOM, V14, 16.0 - 28.0D INSPECTION DRAWING


Description:
POST-COATING INJECTOR COMPONENTS TRANSPORT BAG


Description:
PRE-COATING INJECTOR COMPONENTS TRANSPORT BAG


Description:
TUMBLING PROCEDURE FOR VISIOGEN ACCOMODATING LENS


Description:
SYNCHRONY INJECTOR DESIGN VERIFICATION TEST REPORT


Description:
POWER CALCULATION PROCEDURE FOR SYNCHRONY IOL, V14


Description:
ETO STERILIZATION CYCLE VERIFICATION - LENS INJECT


Description:
SYNC-513-IOL, FEASIBILITY CLINICAL STUDY - CANADA


Description:
SELECTING A CRO & TRANSFER OF RESPONSIBILTY TO CRO


Description:
FUNCTIONAL EVALUATION OF SYNCHRONY INJECTOR-CLINIC


Description:
ASSESSMENT OF CAPSULAR BAG OPACIFICATION AFTER IMP


Description:
ADVERSE EVENTS & UNANTICIPATED ADVERSE DEVICE EFFE


Description:
INSTITUTIONAL REVIEW BOARD/ETHICS COMMITTEE PROCES


Description:
SYNC-514-IOL, FEASIBILITY STUDY, CALI, COLOMBIA


Description:
VISIOGEN ULTRASONIC CLEANER MAINT. SCHEDULE


Description:
VISIOGEN INGERSOL RAND AIR COMP. MAINT. SCHEDULE


Description:
VISIOGEN SPEEDAIRE AIR COMPRESSOR MAINT. SCHEDULE


Description:
QUALITY SYSTEM MANUAL EMPLOYEE ACKNOWLEDGEMENT


Description:
SYNCHRONY INJECTOR ASSEMBLY AND PACKAGING


Description:
MOLD, TOP, 16.0-24.5D, VI 15, INSPECTION DRAWING


Description:
MOLD, MIDDLE(INSERT),16.0-18.5D,VI 15, INSP. DRW.


Description:
MOLD, BOTTOM, 16.0-24.5D, INSPECTION DRAWING


Description:
SYNC-513-IOL, FEASIBILITY CLINICAL STUDY, CANADA


Description:
CONDITIONING & TRANSPORTATION SIMULATION, INJECTOR


Description:
MOVIT CONVERSION TO IN-SITU POWER, VERIFICATION


Description:
OPTICAL INSPECTION PRCDRE OF THE VAIOL ONTHE MOVIT


Description:
SYNC-512-IOL FEASIBILITY INVSTGTNL PLAN-DR. OSSMA


Description:
VERIFICATION OF THE POWER CALC. FOR THE VAIOL V15


Description:
IMPLANT POWER ACLCULATION OF THE VISIOGEN AIOL


Description:
VAIOL ULTEM 1000 MOLD TOOLING FABRICATION, INSPECT


Description:
MOLD TOOLING 1ST ARTICLE INSPECTION REQUEST


Description:
CDM BASE SYSTEM CLINICAL DATA MANAGEMENT DATABASE


Description:
LENS INJECTOR, FINAL ASSEMBLY, 16.0-24.5D, GENERIC


Description:
SYNCHRONY INJECTOR ASSY. & PACKAGING M.P.V. REPORT


Description:
INJECTOR LOT 05164C CLINICAL LOT RELEASE REPORT


Description:
CONDITIONING & TRANSPORTATION SIMULATION REPORT


Description:
VISIOGEN SYNCHRONY LENS PRODUCT SPECIFICATION V15


Description:
CLASSIFICATION OF MEDICAL DEVICES & ACCESSORIES


Description:
IMPLANTATION OF A DUAL-OPTIC IOL W/A NEW INJECTOR


Description:
SYNCHRONY INJECTION SYSTEM 1 YEAR ACCELERATED AGIN


Description:
AXIAL DSPLCMNT IN RADIAL COMPRSN TEST OF THE VAIOL


Description:
INJECTOR PART RCVNG INSP. RTR, BASE,INJECTOR,PAD,P


Description:
INJECTOR PART RCVNG INSP. RUTR, COATING ZONE,SLIDE


Description:
INJECTOR PART RCEVNG INSP. RUTR, COATING ZONE,NOZZ


Description:
INJECTOR PART RECEIVING INSP. ROUTER, PLUNGER, INJ


Description:
INJECTOR PART RECEIVING INSP. ROUTER, WEDGE PLATE


Description:
INJECTOR PART RECEIVING INSP. ROUTER, CAP, INJECTO


Description:
INJECTOR PART RECEIVING INSP. ROUTER, COVER, INJEC


Description:
INJECTOR PART RECEIVING INSP. ROUTER, BASE, INJECT


Description:
INJECTOR PART RECEIVING INSP. ROUTER, CLIP, PLUNGE


Description:
INJECTOR PART RECEIVING INSP. ROUTER, SLIDE, INJEC


Description:
INJECTOR PART RECEIVING INSP. ROUTER, NOZZLE INJEC


Description:
VERIFICATION OF THE SYNCHRONY SYSTEM REPORT


Description:
INJECTOR COMPONENTS INSPECTION, PREPARATION & REWO


Description:
DYNAMIC RESPONSE TIME OF V15 SYNCHRONY LENS


Description:
LENS INJECTOR, FINAL ASSEMBLY, 16.0-28.0D, GENERIC


Description:
MOLD, MIDDLE(INSERT), 25.0-28.0D, VI 15, INSP.DRAW


Description:
MOLD, TOP, 16.0-28.0D, VI15, INSP. DRAWING


Description:
MOLD, BOTTOM, 16.0-28.0D, VI 15, INSP. DRAWING


Description:
VERIFICATION OF THE PWER CALCULATION FOR THE VAIOL


Description:
LABEL, CAUTION-INVESTIGATIONAL DEVICE. LIMITED BY


Description:
LABEL, VISIOGEN LOGO, WHITE & BLUE, 2" x 2"


Description:
I.Q. AND O.Q. OF THE ULTRASONIC CLEANERS


Description:
MOLDING P.Q. FOR SYNCHRONY LENS-AMEND. TO R03-021


Description:
INJCTR PRT RECVNG INSPCTN ROUTR, COATING ZON SLIDE


Description:
INJCTR PRT RECVNG INSPCTN ROUTR, COATING ZON NOZZL


Description:
REFRACTIVE INDEX & COMPENSATOR MEASUREMENT


Description:
REFRACTIVE INDEX & DISPERSION MEASUREMENT


Description:
SYNC. INJECT. SYSTEM USING S.S. 3 YR. ACCLRTD AGIN


Description:
VAIOL ULTEM 1000 MOLD TOOLING, FABRCTN, INSPECTN &


Description:
VI15 MOLD,MIDDLE(INSRT), 25.0-28.0D, INSP. DRAWING


Description:
VI15 MOLD,MIDDLE(INSRT), 19.0-24.5D, INSP. DRAWING


Description:
VI15 MOLD,TOP, 16.0-28.0D, INSP. DRAWING


Description:
VI15 MOLD,MIDDLE(INSRT), 16.0-18.5D, INSP. DRAWING


Description:
VI15 MOLD,BOTTOM, 16.0-28.0D, INSP. DRAWING


Description:
LENS INJECTOR, FINAL ASSY., S.S. COATING,16-28.0D


Description:
COATING PROCDR FOR SYNCHRONY INJTR NOZZL & SLID C


Description:
MIXNG & STORNG OF HYDROPHILIC COATNG MATRAL FOR CO


Description:
OPTICAL INSPECTION PROCEDURE OF THE VAIOL ON THE M


Description:
IMPLANT POWER CALCULATION OF THE VAIOL, VI 17


Description:
RECEIVI, INSP., & TESTING OF SILICONE RAW MATERIAL


Description:
SURFACE SOLUTIONS MATERIAL INSPECTION FORM


Description:
TEST RECORD DATA SHEET-VISC., %, SOLID WT. & Ph


Description:
JEWEL CASE COVER, IN THE WORDS OF THE SURGEON


Description:
LENS INJECTOR, FINAL ASSY.,16.0-28.0D, GENERIC


Description:
CLINICAL STUDY MATERIAL CALCULATION & TRACEABILITY


Description:
MASTER VALIDATION PLAN SUMMARY OF THE VAIOL SYSTEM


Description:
PROCESS FMEA OF THE VISIOGEN SYNCHRONY LENS SYSTEM


Description:
PROCESS FMEA FOR SYNCHRONY INJECTOR ASSY.-OBSOLETE


Description:
PROCESS FMEA FOR VISIOGEN AIOL - OBSOLETE


Description:
DESIGN FMEA REPORT OF THE VAIOL ASSEMBLY


Description:
SYNCHRONY LENS ASSY. PROCESS MANF. OPRTNS ANALYSIS


Description:
BIOCOMPATIBILITY TESTS FOR THE VAIOL INJECTION SYS


Description:
IQ, OQ & OPTICAL PERFORMANCE QUAL. OF THE MOVIT


Description:
VERIFICATION OF THE POWER CALC. FOR THE VAIOL VI15


Description:
IMPLANT POWER CALCULATION OF THE VISIOGEN IOL


Description:
I.Q. & O.Q. OF THE OGP SMARTSCOPE FLASH 200


Description:
PRODUCT DEV. PLAN FOR SYNCHRONY DUAL OPTIC IOL SYS


Description:
IQ/OQ FOR THE VWR HORIZONTAL AIR FLOW OVEN


Description:
IQ/OQ FOR THE SERVO IMPACT 2 CNC MILLING MACHINE


Description:
I.Q./O.Q. FOR THE PRECISION LATHE OPTOFORM 40


Description:
IQ/OQ & OPTICAL PERFORMANCE OF THE MOVIT EQUIPMENT


Description:
INJECTOR COMP. INSPEC., PREP., & REWORK PROCEDURE


Description:
CLEANING PRCDR FOR SYNCHRONY INJCTR NOZZLE & SLIDE


Description:
I.Q./O.Q. REPORT OF THE CHATILLON TESTER


Description:
INJECTOR COMP. INSPECTION, PREP. & REWORK PROCEDUR


Description:
I.Q./O.Q. FOR THE PRESISION LATHE OPTOFORM 40


Description:
I.Q./O.Q. FOR THE SERVO IMPACT 2 CNC MILLING MACH.


Description:
TEST REPORT-SEAL STRENGTH OF VISIOGEN PACKAGE


Description:
PULL TEST PROCEDURE USING THE CHATILLON TESTER


Description:
MOLDING PROCESS QUAL. FOR SYNCHRONY LENS-AMENDMENT


Description:
I.Q./O.Q. FOR THE VWR HORIZONTAL AIR FLOW OVEN


Description:
LABEL, PRODUCT IDENTIFICATION, CE MARK VERSION


Description:
RISK ASSESSMENT, CDMBASE SYSTEM FOR PROTOCOL SYNC-


Description:
SYSTEM VALIDATION PROTOCOL, CDMBASE SYSTEM FOR PRO


Description:
MIXING,DEGASSING&STORING OF SILICONE MATRL. FOR FA


Description:
REC., INSPT. & TESTING OF SILICONE RAW MATERIAL


Description:
MOLD, MIDDLE(INSERT), 25.0-28.0D, VI 15, INSP. DRW


Description:
MOLD, MIDDLE(INSERT), 19.0-24.5D, VI 15, INSP. DWG


Description:
MOLD, TOP, 16.0-28.0D, VI 15, INSPECTION DRAWING


Description:
MOLD, MIDDLE(INSERT), 16.0-18.5D, VI 15, INSP. DWG


Description:
INJECTOR ASSY. PROCESS CHARACTERIZATION PROTOCOL


Description:
INSTALLATION QUALIFICATION PROTOCOL, CDMBASE SYSTM


Description:
VERIFICATION OF THE SYCHRONY SYSTEM REPORT


Description:
OPERATIONAL & PERFORMANCE QUALIFICATION PROTOCOL


Description:
INJECTOR ASSEMBLY PROCESS CHARACTERIZATION REPORT


Description:
COATED SLIDE, COATING ZONES FOR 625-002 SLIDE


Description:
COATED NOZZLE, COATING ZONES FOR 625-001 NOZZLE


Description:
LENS PLCMNT & ANGLE MESRMNT GR&R & RIB-TO-BASE SPE


Description:
INJECTOR LENS PLACEMENT AND ANGLE INSPCTN. OVERLAY


Description:
INJECTOR LENS PLACEMENT & LENS ANGLE MEASUREMENT


Description:
SOFTWARE VALIDATION REPORT, VISIOGEN MOVIT SYS.


Description:
SOFTWARE VALIDATION PROTOCOL, VISIOGEN MOVIT SYS.


Description:
SOFTWARE REQUIREMENTS, VISIOGEN MOVIT SYSTEM


Description:
LABEL, VISIOGEN LOGO, WHITE & BLUE, 2 x 2"


Description:
CLEANING PRCDRE FOR SYNCHRONY INJECTOR NOZZLE & SL


Description:
M.P.V. REPORT-SYNCHRONY INJECTOR COMPONENTS PROCES


Description:
LENS PLCMNT & ANGLE MSRMNT GR&R & RIB-TO-BASE SPEC


Description:
SILICONE MIXING PROCESS QUALIFICATION (UVAM UV MAT


Description:
MIXING, DEGASSING & STORNG OF SLCNE MTRL(UVAM UV M


Description:
COATING EVALUATION OF PLASMA METHOD vs VAPOR DEGRE


Description:
INJECTOR COMPONENTS REWORK AND/OR CLEANING LOG


Description:
INJECTOR LENS PLACEMENT & ANGLE INSPECTION OVERLAY


Description:
INJECTR COMPNTS INSPCTN, PREPARATN & REWORK PROCDR


Description:
CLENNG PRCDR FOR SYNCHRNY INJCTR NOZZLE&SLIDE COMP


Description:
SYNCHRONY INJECTOR MATURE ASSEMBLY & PACKAGING PRO


Description:
INJCTR PART RECVNG INSPCTN ROUTR,BASE,PAD, 625-014


Description:
INJCTR PART RECVNG INSPCTN ROUTR,CTD SLID, 625-012


Description:
INJCTR PART RECVNG INSPCTN ROUTR,CTD NOZZ, 625-011


Description:
INJCTR PART RECVNG INSPCTN ROUTR,PLUNGER, 625-008


Description:
INJCTR PART RECVNG INSPCTN ROUTR,WEDGE PL, 625-007


Description:
INJCTR PART RECVNG INSPCTN ROUTR,CAP, 625-006


Description:
INJCTR PART RECVNG INSPCTN ROUTR,COVER, 625-005


Description:
INJCTR PART RECVNG INSPCTN ROUTR,BASE INJ, 625-004


Description:
INJCTR PART RECVNG INSPCTN ROUTR,CLIP PLU, 625-003


Description:
INJCTR PART RECVNG INSPCTN ROUTR,SLIDE, 625-002


Description:
INJCTR PART RECVNG INSPCTN ROUTR,NOZZLE, 625-001


Description:
CLEANING PROCEDURE FOR LENS LINER & LENS TRAY


Description:
INSTALLATION QUALIFICATION REPORT-CDMD SYSTEM SYNC


Description:
OPERATION & PERFORMANCE QUALIFICATION-CDMD SYSTEM


Description:
VAIOL ULTEM 1000 MOLD TOOLING,FBRCTN,INSPCTN & REL


Description:
INJECTOR NOZZLE RAIL FLASH REMOVAL FIXTURE


Description:
2X ETO STERILIZATION QUALIFICATION - LENS


Description:
MOLD-MIDDLE(INSERT) 19.0-24.5D, VI 15, INSPEC. DRW


Description:
MOLD-TOP, 16.0-28.0D, VI 15, INSPECTION DRAWING


Description:
MOLD-BOTTOM, 16.0-28.0D, VI 15, INSPECTION DRAWING


Description:
ENVIRNMENTAL MONITORING OF PRODUCT AND CEA AREA


Description:
SYNCHRONY INJECTOR QUAL. OF MODIFIED SLIDE DESIGN


Description:
SYNCHRONY INJECTION SYSTEM PLASMA TREATED 2 YEAR A


Description:
FINAL SYSTEM VALIDATION REPORT-CDMBASE SYSTEM


Description:
BIOCOMPATIBILITY TESTS OF THE VAIOL MADE W/UVAM UV


Description:
SYNCHRONY INJECTOR MATURE ASSY. & PACKAGING PROCES


Description:
LENS INJECTOR, FINAL ASSY., 16.0-28.0D, GENERIC


Description:
INJECTOR COMPONENTS INSPCTN, PREPTN & REWRK PROCDR


Description:
MASTER VALIDTN PLAN SUMMARY OF THE VAIOL SYNCRONY


Description:
MOLD, TOP, 16.0-24.5D, VI 16, INSPCTN. DRAWING


Description:
MOLD, MIDDLE(INSERT), 19.0-24.5D, VI 16, INSP. DRW


Description:
MOLD, MIDDLE(INSERT), 16.0-18.5D, VI 16, INSP. DRW


Description:
MOLD, BOTTOM, 16.0-24.5D, VI 16, INSPCTN. DRAWING


Description:
BIOCOMPATIBILITY TESTS FOR THE VAIOL INJECTN. SYST


Description:
TUMBLING PROCEDURE FOR VAIOL, MODEL VI 16


Description:
DIMENSIONAL INSPECTION OF VISIOGEN IOL, VI 16


Description:
MOLD, TOP, 16.0-24.5D, VI 16, INSPECTION DRW.


Description:
MOLD, MIDDLE(INSERT), 19.0-24.5D, VI16, INSPECTION


Description:
MOLD, MIDDLE(INSERT), 16.0-18.5D, VI16, INSPECTION


Description:
MOLD, BOTTOM, 16.0-24.0D, VI 16, INSPECTION DRW.


Description:
MIXED SURFACE SOLUTIONS COATING MATERIAL


Description:
MIXING & STORING OF HYDROPHILLIC COATING MATERIAL


Description:
OPTICAL INSPCTION PRCDRE OF THE VAIOL ON THE MOVIT


Description:
VERFCTN OF THE PWR CALC. PRCISON FOR THE VAIOL V15


Description:
BIOCOMPAT. TESTS FOR THE VAIOL SYNCHRONY INJECT. S


Description:
TUMBLING PROCEDURE FOR VAIOL MODEL, VI 16


Description:
TUMBLING PROCEDURE FOR VAIOL, MODEL VI 15


Description:
SYNCHRONY INJECTION SYSTEM 1 YEAR AGING STUDY


Description:
LENS-INJECTOR, FINAL ASSEMBLY, 16.0-28.0D, GENERIC


Description:
INJECTOR COMPONENTS INSPCTN, PRPRTN & REWORK PROCD


Description:
VAIOL ULTEM 1000 MOLD TOOLING FBRCTN,INSPTN & RELE


Description:
MOLD TOOLING 1st ARTICLE INSPECTION REQUEST


Description:
SYNC. INJCTN. SYSTM USING SURFACE SOLUTN COATING C


Description:
BIOCMPTBLTY TESTS OF THE SYNCHNY IOL PRDCED FROM M


Description:
VERIFICATN OF THE POWER CALCTN FOR THE VAIOL VI 16


Description:
MXNG,DEGSSNG & STORING OF SILICONE MATRL UVAM UV M


Description:
MXNG,DEGSSNG & STORING OF SILICONE MATRL FOR FABTN


Description:
TUMBLING PROCEDURE FOR VAIOL MODEL VI 16


Description:
TUMBLING PROCEDURE FOR VAIOL MODEL VI 15


Description:
ULTRASONIC CLEANING LINER - 150ML BEAKER


Description:
INJCTR PRT RECVNG INSPCTN ROUTR, COATNG ZONES,SLID


Description:
INJCTR PRT RECVNG INSPCTN ROUTR, COATNG ZONES,NZZL


Description:
MIXING & STRNG OF HYDROPHILLIC COATING MTRL FOR CT


Description:
SURFACE SOLUTIONS COATING FORMULATION QUAL. REPORT


Description:
DEVLPMNT OF IN-HOUSE COATNG PROCSS FOR INJCTR PART


Description:
REPORT FOR P06-023 O.Q. FOR SYNC601-IOL-PHASE 2


Description:
FINAL SYSTEM VALIDATION REPORT-PHASE II, CDMDATABA


Description:
SILICONE MIXING PROCESS QUAL(UVAM UV MATERIAL)


Description:
INJCTR PRT RCIVNG INSPCTN ROUTER,COTNG ZNS, SLIDE


Description:
INJCTR PRT RCIVNG INSPCTN ROUTER,COTNG ZNS, NZZLE


Description:
SURFACE SOLUTIONS COATING PROCESS DEVELOPMENT REPT


Description:
SYNCHNY INJCTN SYSTM USING SRFC SOLUTN COTNG CONDT


Description:
COTNG PRCDR FOR SYNCHNY INJCTR NZZLE & SLIDE COMPO


Description:
MIXNG & STORNG OF HYDROPHILLIC COTNG MATRL FOR COA


Description:
ARBOR PRESS GAP DISTANCE-PREVENTIVE MAINTENANC LOG


Description:
IN-HOUSE 1 YR. ACCLRTED AGING STDY RPRT FOR S.S CO


Description:
S.S. COATNG MATRL. DESGN & DVLPMNT PLAN FOR THE VI


Description:
INSPECTION REPORT-POST STERILE LOT RELEASE


Description:
CLEANING & DISINFECTING OF RETURNED PRODUCT


Description:
CLEANING PROCEDURE FOR SYNCH. INJECTR NZZL & SLDE


Description:
ARBOR PRESS GAP DISTANCE-PREVENTATIVE MAINTENANCE


Description:
VERFCTN OF THE PWR CALCTN FOR THE VAIOL V15, MONCL


Description:
MIXING QUAL STUDY FOR S.S. COATING MATERIALS


Description:
LENS INJECTOR, FINAL ASSY., S.S., STRIPED COATING,


Description:
STRIPED COATING ZONES FOR 625-001 NOZZLE


Description:
COATING PROCEDURE FOR SYCH INJCTR NZZL & SLDE COMP


Description:
SURFACE SOLUTIONS COATING CHARACTERIZATION STUDY


Description:
INSPECTION REPORT-COATED COMPONENTS LOT RELEASE


Description:
MODIFIED ARBOR PRESS BLOCK FOR INJECTOR ASSEMBLY


Description:
MIXING & STORING OF HYDROPHILIC CTNG MTRL. FOR INJ


Description:
BIOCOMPATIBILITY TEST FOR THE VISIOGEN INJTN SYTM


Description:
NUSIL SILICONE MATRL MED-6820 SHELF LIFE EXTNTN LO


Description:
MIXING QUALFCTN STUDY RPT. FOR S.S. COATING MATERI


Description:
INJECTOR PRESS II FOR INJECTOR BASE COVER ASSY. MA


Description:
INJECTOR PRESS II-PREVENTIVE MAINTENANCE LOG


Description:
INJECTOR COMPONENTS INSPECTION, PREP. & REWORK PRO


Description:
DVD/CD LABEL, IN THE WORDS OF THE SURGEON


Description:
STERILIZATION VALIDATION - LENS INJECTOR


Description:
VERIF. OF THE CNVSN FROM UBM DIM. TO PHYSCL DIMENS


Description:
TESTING OF FATIGUE DURABILITY OF THE VAIOL, VI 15


Description:
VISIOGEN INGERSOL RAND AIR COMPRESSOR MAINTENANCE


Description:
CLEANING EFFECTS ON FRICTION & COATABILITY


Description:
WATER CLEANED NOZZLE & SLIDE & LOCAL IPA TREATED F


Description:
QSM, SOP, WI, MAP, PROTOCOL AND REPORT PREPARATION


Description:
SYNCHRONY INJECTION SYSTEM USING S.S.COATING CONDI


Description:
POST INJECTION LENS FAILURE ANALYSIS STUDY


Description:
COATING PRCDRE FOR SYNCHRONY INJCTR NOZZLE & SLIDE


Description:
SURFACE SOLUTION MIXING & STRIPED COATING PROCESS


Description:
MIXING & STORING OF HYDROPHILLIC COATING MATRL FOR


Description:
INJCTR NZZLE & SLIDE CLEANING PROCESS W/WATER ONLY


Description:
PROCESS FMEA RPRT OF S.S. COATING FOR VISIOGEN SYN


Description:
S.S. MIXING & STRIPED COATING PROCESS QUAL. REPORT


Description:
MIXING & STORING OF HYDROPHILLIC COATING MTRL FOR


Description:
INJCTR NZZL & SLIDE CLEANING PROCESS QUAL W/WATER


Description:
CLEANING PRCDR FOR SYNCHRNY INJCTR NZZL & SLDE COM


Description:
INJCTR PRT INSPCTN ROUTR S.S. COATNG ZNS,NZZL,625-


Description:
INJCTR PRT INSPCTN ROUTR S.S. COATNG ZNS,SLIDE,625


Description:
COATING PRCDR FOR SYNCHNY INJTR NZZL & SLIDE COMPO


Description:
POST INJECTION LENS FAILURE ANALYSIS REPORT


Description:
SHIPPING FORM: STERILE LABELING CONFIGURATION


Description:
LENS INJECTOR, FINAL ASSY.,S.S,STRIPED COATING, GE


Description:
VISIOGEN SPEEDAIRE AIR COMPRESSOR MAINTENANCE


Description:
MIXING, DEGASSING & STORING OF SILICONE MATRL. FOR


Description:
CDMBASE SYSTM PROTOCOL #SYNC-601-SYSTEM DESIGN SPE


Description:
CDMBASE VALIDATION SPECIFICATION PROTOCOL SYNC-601


Description:
IMPLANTATION OF A DUAL OPTIC IOL W/A 3.2mm INJECTO


Description:
VRFICTN OF THE POWER CALC. FOR THE VIOL VI17,BINOC


Description:
FABRICATION OF VISIOGEN ACCOMMODATING IOL


Description:
S.S.CTNG MTRL DESGN & DEVLPMNT PLAN FOR THE VISIOG


Description:
RECEIVING,INSPECTION&TESTING OF COATING RAW MATERI


Description:
VISIOGEN SYSCHRONY LENS, VERSION 15, PRODUCT SPEC.


Description:
UBM REPORT OBJECTIVE TESTING-EYEONICS:CHU & DAVIDO


Description:
UNDERSANDING & EXPANDING THE SCOPE OF ITRACE


Description:
VAIOL ULTEM 1000 MOLD TOOLING FABRCTN. INSPCTN. &


Description:
CORRECTIVE ACTION & PREVENTIVE ACTION LOG (CAPA)


Description:
SEMI-AUTOMATIC INJECTOR PRESS & INJECTOR BASE


Description:
INCIDENT REPORTING PROCEDURE (VIGILANCE SYSTEM)


Description:
FIELD SAFETY CORRECTIVE ACTION PROCEDURE (VIGILAN


Description:
ADVERSE EVENT DETERMINATION & ASSESSMENT FORM


Description:
COMPLAINT EVALUATION & TECHNICAL ANALYSIS


Description:
P.M. LOG - SEMI-AUTOMATIC INJECTOR PRESS


Description:
LENS INJECTOR, FINAL ASSY.,S.S. COATING, 16.0-28.0


Description:
PURCHASING & ACQUIRING MANF. & FACILITY EQUIPMENT


Description:
EQUIPMENT INSTALLATION QUALIFICATION (I.Q.) CHECKL


Description:
"A","X" AND DEVIATION LEVEL DOCUMENTATION RELEASE


Description:
QSM, SOP, WI, MAP, PROTOCOL & REPORT PREPARATION


Description:
LENS INJECTOR, FINAL ASSY., S.S. COATING, 16.0-28.


Description:
JEWEL CASE COVER, A REVOLUTIONARY MOVEMENT IN VISI


Description:
DVD/CD LABEL, A REVOLUTIONARY MOVEMENT IN VISION


Description:
RECEIVING, INSPCTN & TESTING OF SILICONE RAW MATRL


Description:
INJTR. PART INSPCTN. ROUTER S.S. COTING ZNES, NOZZ


Description:
INJTR. PART INSPCTN. ROUTER S.S. COATING ZONES, SL


Description:
LENS INJECTOR, FINAL ASSY., (S.S.) 16.0-28.0D, GEN


Description:
MIXING, DEGASNG & STORNG OF SILICN MTRL FOR FBRCTN


Description:
MOVE-PACKAGING RE-QUALIFICATION FOR VISIOGEN FACIL


Description:
IMPLANTATION OF A DUAL-OPTIC IOL WITH AN INJECTOR


Description:
CLEANROOM FACILITIES VALIDATION FOR 2 GOODYEAR,IRV


Description:
MOVE-COMPRESSED AIR SYSTEM-IQ & FUNCTIONAL VERIFIC


Description:
MOVE-VALIDATION MASTER PLAN, VISIOGEN FACILITY


Description:
MOVE-IQ/OQ OF VISIOGEN DEIONIZED WATER SYSTEM


Description:
CLEANING REQUIREMENTS, RESTRICTIONS & GUIDELINES


Description:
Cleanroom B Facility Validation at 2 Goodyear


Description:
Cleanroom A Facility Validation at 2 Goodyear


Description:
IQ & FUNCTIONAL VERIFICATION OF THE CHATILLON TEST


Description:
IQ & FUNCTIONAL VERIFICATION OF OGP SMARTSCOPE FLA


Description:
IQ/OQ OF THE MOVIT OPTICAL MEASUREMENT SYSTEM


Description:
3-LOT VERIFICATION & CYTOTOXICITY TESTING


Description:
IQ & OQ FOR THE VWR HORIZONTAL AIR FLOW HEPA OVEN


Description:
SHIPPING FORM STERILE LABELING CONFIGURATION


Description:
LENS INJECTOR,FINAL ASSY.,S.S. STRIPED COATING,16-


Description:
COATING ZONES FOR 625-001 NOZZLE, FULL COATING


Description:
COATING PROCDR FOR SYNCRNY INJCTR SLIDE COMPONETS


Description:
COATING PROCDR FOR SYNCHRNY INJCTR NZZL STRIPD COA


Description:
COATING PROCDR FOR SYNCHRNY INJCTR NZZL FULL COATI


Description:
I.P.R.I.R. BASE, INJECTOR, PAD PRINTING, 625-004-P


Description:
LOW & HIGH TEMP. FEASBLTY STDY FOR COATNG CURING P


Description:
RMP-VISIOGEN SYNCHRONY IOL SYSTEM V15 W/INJECTOR


Description:
SYNCHRONY IOL & INJECTION SYSTEM: 3 YEAR REAL TIME


Description:
MULTIPLE REGRESSION METHOD FOR CALCULATING IOL POW


Description:
MOVE-IQ & FUNCTIONAL VERIFICATION OF THE CHATILON


Description:
MOVE-IQ & FUNCTIONAL VERIFICATION OF OGP SMARTSCOP


Description:
MOVE-IQ/OQ OF THE MOVIT OPTICAL MEASUREMENT SYSTEM


Description:
S.S. COATING RELEASE DURING LENS IMPLANTATION-ENGI


Description:
INJECTOR COATING RELEASE STUDY W/SYNCHRONY LENS &


Description:
IQ & OPERATIONAL CHARTR. FOR THE VWR HORZNTL AIR F


Description:
COMPRESSED AIR SYSTEM QUALIFICATION REPORT


Description:
LOW AND HIGH TEMPERATURE FEASIBILITY STUDY FOR COA


Description:
PROCESS QUALIFICATION OF THE STRIPED COATING OF IN


Description:
REPORT-VISIOGEN FACILITY MOVE-INSTALLATION AND OPE


Description:
VISIOGEN DI WATER MAINTENANCE SCHEDULE (ID 0264)


Description:
FACILITIES VALIDATION FOR CLEANROOM B AND GOWNING


Description:
FACILITIES VALIDATION FOR CLEANROOM A AND GOWNING


Description:
CLEANING PROCEDURE FOR LENS LINER AND LENS TRAY


Description:
CLEANING PROCEDURE FOR SYNCHRONY INJECTOR NOZZLE A


Description:
SYNCHRONY POWER CALCULATION USING "IOLPOWER_NOLT.X


Description:
INTERNAL AUDIT CORRECTIVE AND PREVENTIVE ACTION RE


Description:
VISIOGEN SYNCHRONY IOL SYSTEM (V15 LENS WITH INJEC


Description:
SYNCHRONY LENS INJECTOR SYSTEM FOLDING VERIFICATIO


Description:
COATING PROCEDURE FOR SYNCHRONY INJECTOR SLIDE COM


Description:
COATING PROCEDURE FOR SYNCHRONY INJECTOR NOZZLE-ST


Description:
COATING PROCEDURE FOR SYNCHRONY INJECTOR NOZZLE-FU


Description:
MIXING AND STORING OF HYDROPHILIC COATING MATERIAL


Description:
ENGINEERING STUDY TO DETERMINE LENS CURING TEMPERA


Description:
FABRICATION OF VISIOGEN ACCOMIDATING INTRAOCULAR L


Description:
POST STERILE INSPECTIONS OF VISIOGEN IOL


Description:
QUALIFYING AND RELEASING THE OVEN ID# 0263 TO OPER


Description:
CLEANROOM REQUIREMENTS, RESTRICTIONS AND GUIDELINE


Description:
TESTING OF CLEANROOM A AND CLEANROON B AT 2 GOODYE


Description:
INJECTOR PART RECEIVING INSPECTION ROUTER COATING


Description:
SPECIATION OF CLEANROOM A AND CLEANROOM B AT 2


Description:
LOW AND HIGH TEMPERATURE FEASIBILITY STUDY FOR FUL


Description:
AXIAL COMPRESSION TEST OF THE VISIOGEN AIOL, V15


Description:
MECHANICAL AND OPTICAL TESTING OF THE V15 INJECTOR


Description:
PERFORMING MTF MEASUREMENTS ON THE MOVIT


Description:
MIDDLE (INSERT) MOLD INSPECTIONS VERSON VI16


Description:
TUMBLING PROCEDURE FOR VISIOGEN ACCOMIDATING LENS,


Description:
VI16 MOLD-TOP  16.0D-24.5D INSPECTION DRAWING


Description:
VI16 MOLD-MIDDLE (INSERT) 19.0D-24.5D INSPECTION


Description:
VI16 MOLD-MIDDLE (INSERT) 19.0D-24.5D DRAWING


Description:
VI16 MOLD-MIDDLE (INSERT) 16.0D-18.0D INSPECTION


Description:
VI16 MOLD-MIDDLE (INSERT) 16.0D-18.5D DRAWING


Description:
VI16 MOLD-BOTTOM INSPECTION (DRAWING) 16.0D-24.5D


Description:
V15 MOLD MACHINING OPERATIONS PROGRAM NUMBERS


Description:
INSPECTION DATA SHEET FABRICATION OF ULTEM PLASTIC


Description:
MOLD INSERT V15 "HIGH RANGE" SERIAL NUMBER LOG


Description:
MOLD INSERT V15 "MIDDLE RANGE" SERIAL NUMBER LOG


Description:
MOLD INSERT V15 "LOW RANGE" SERIAL NUMBER LOG


Description:
FABRICATION OF ULTEM 1000 PLASTIC MOLD TOOLS (INSE


Description:
FABRICATION OF ULTEM 1000 PLASTIC MOLD TOOLS (TOP


Description:
FABRICATION OF ULTEM 1000 PLASTIC MOLD TOOLS (BOTT


Description:
SET-UP OPTOFORM 40 LATHE FOR VAIOL ULTEM MOLD


Description:
ROUTING-FABRICATION OF ULTEM MOLD TOOLS (TOP)


Description:
BOM-FABRICATION OF ULTEM MOLD TOOLS (TOP)


Description:
ROUTING-FABRICATION OF ULTEM MOLD TOOLS (INSERT)


Description:
BOM-FABRICATION OF ULTEM MOLD TOOLS (INSERT)


Description:
ROUTING-FABRICATION OF ULTEM MOLD TOOLS (BOTTOM)


Description:
BOM-FABRICATION OF ULTEM MOLD TOOLS (BOTTOM)


Description:
BOM-FABRICATION OF ULTEM MOLD TOOLS (INSERT BL


Description:
ROUTING-FABRICATION OF ULTEM MOLD TOOLS (INSERT BL


Description:
ROUTING-FABRICATION OF ULTEM MOLD TOOLS (BOTTOM BL


Description:
BOM-FABRICATION OF ULTEM MOLD TOOLS (BOTTOM BLANK)


Description:
BOM-FABRICATION OF ULTEM MOLD TOOLS (TOP BLANK


Description:
ROUTING-FABRICATION OF ULTEM MOLD TOOLS (TOP BLANK


Description:
FINAL CLEANING AND PACKAGING OF VISIOGEN IOLS


Description:
INJECTOR COMPONENTS INSPECTION AND PREPARATION PRO


Description:
SETUP LOG - SEMI-AUTOMATIC INJECTOR PRESS (P/N 400


Description:
INJECTOR PRESS II (P/N 400-335) GAP DISTANCE - SET


Description:
FINAL PACKAGING AND CLEANING OF VISIOGEN IOLS


Description:
VISIOGEN SYNCHONY DUAL OPTIC ACCOMMODATING INTRAOC


Description:
AXIAL COMPRESSION TEST OF THE VISIOGEN AIOL


Description:
MECHANICAL AND OPTICAL TESTING OF THE V15 VISIOGEN


Description:
OPTICAL INSPECTION PROCEDURE OF THE VISIOGEN IOL


Description:
SURFACE SOLUTIONS MIXING AND COATING LOG SHEET


Description:
INSPECTION REPORT - LENS INJECTOR POST STERILE LOT


Description:
PER-STERILE FUNCTIONAL TEST OF INJECTOR WITH SS


Description:
POST-STERILE INSPECTIONS OF VISIOGEN AIOL


Description:
VISIOGEN SYNCHRONY IOL SYSTEM MODEL: SYNC-100


Description:
OPERATIONAL QUALIFICATION (OQ) FOR THE OPTOFORM 40


Description:
NUSIL MED6-6820 TESTING COMPENDIUM AND FDA DEVICE


Description:
NUSIL MED-6820 TESTING COMPENDIUM AND FDA DEVICE M


Description:
VAIOL ULTEM 1000 MOLD TOOLING FABRICATION INSPECTI


Description:
V18 ASPHERIC MOLD TOP 16.0D-28.0D INSPECTION DRAW


Description:
OPERATIONAL QUALIFICATION AND SOFTWARE VALIDATION


Description:
INTERFEROMETRIC MEASUREMENT OF ASPHERIC MOLD


Description:
FABRICATION OF VISIOGEN ACCOMODATING INTRAOCULAR


Description:
OPTICAL INSPECTION PROCEDURE OF THE VISIOGEN INTRA


Description:
FABRICATION OF ULTEM PLASTIC "MOLD TOP ASPHERIC" F


Description:
INTERFEROMETRIC MEASUREMENTS OF ASPHERIC MOLD


Description:
COMPRESSED AIR SYSTEM - FUNTIONAL RE-VERIFICATION


Description:
RISK MANAGEMENT PLAN - VISIOGEN SYNCHRONY IOL SYST


Description:
PROCESS CHALLENGE DEVICE (EPCD) EXTERNAL


Description:
MOLD TOP V18 (ASPHERICAL) SERIAL NUMBER LOG


Description:
MOLD MACHINING OPERATING PROGRAM NUMBERS


Description:
FABRICATION OF ULTEM 1000 PLASTIC MOLD TOOL (TOP)


Description:
BOM-FABRICATION OF ULTEM MOLD TOOL (TOP) FOR ASPHE


Description:
ROUTER-FABRICATION OF ULTEM 1000 PLASTIC MOLD TOOL


Description:
V18 LENS DESIGN DIFFERENCE FROM V15 LENS DESIGN


Description:
FACILITIES VALIDATION FOR CLEANROOM B AT 2 GOODYEA


Description:
INSTALLATION AND OPERATIONAL QUALIFICATION REPORT


Description:
VISIOGEN FACILITY MOVE - VALIDATION MASTER PLAN RE


Description:
REPORT, MOVE 3-LOT VERIFICATION AND CYTOTOXICITY T


Description:
MOVIT CONVERSION TO IN-SITU POWER, VERIFY, V18


Description:
VERIFICATION OF THE POWER CALCULATION FOR THE VIOS


Description:
IMPLANT POWER CALCULATION OF THE VISIOGEN IOL, V18


Description:
PROJECT PLAN FOR SYNCHRONY DUAL OPTIC ACCOMMODATIN


Description:
VISIOGEN SYNCHRONY DUAL OPTIC ACCOMMIDATING INTRAO


Description:
INSTALLATION AND OPERATIONAL QUALIFICATION OF DI W


Description:
V18 (ASPHERIC) LENS INJECTOR FINAL ASSEMBLY


Description:
VAIOL ULTEM 1000 MOLD TOOLING INSPECTION AND RELEA


Description:
PURCHASING AND ACQUIRING MANUFACTURING AND FACILIT


Description:
EQUIPMENT TRACKING, PREVENTIVE MAINTENANCE AND CAL


Description:
OPERATIONAL QUALIFICATION (OQ) FOR THE OPTIFORM


Description:
OPERATIONAL QUALIFICATION (OQ) FOR THE SERVO IMPAC


Description:
BENCHTOP VERIFICATION OF MTF AND DEPTH OF FOCUS OF


Description:
EXTERNAL PROCESS CHALLENGE DEVICE (EPCD)


Description:
TOP DOWN ANALYSIS - VISIOGEN SYNCHRONY ACCOMMIDATI


Description:
SOFTWARE VALIDATION FOR THE EMCO CNC LATHE #0288


Description:
SURFACE SOLUTIONS COATING MATERIAL, MIXED


Description:
COATING PROCEDURE FOR SYNCHRONY INJECTOR NOZZLE -


# tblDocuments

Description:
Label, Visiogen Logo, White & Blue, 2" x 2"


Description:
Jewel Case Cover, "In the Words of the Surgeon"


Description:
DVD/CD Label, "In the Words of the Surgeon"


Description:
DVD/CD Label, "A Revolutionary Movement in Vision..."


Description:
Jewel Case Cover, "A Revolutionary Movement in Vision..."


Description:
Testing of Optic Tilt & Decentration of VAIOL


Description:
Dynamic Fatigue Testing Proceduce of the  VAIOL


Description:
Axial Displacement In Radial Compression Test of the VAIOL


Description:
Implant Power Calculation of the VISIOGEN AIOL


Description:
Design Qualification Test for the VISIOGEN AIOL


Description:
Implant Power Calculation of the VISIOGEN AIOL V10&11


Description:
Implant Power Calculation of the VAIOL V12


Description:
Injector Folding Evaluation of Visiogen Lens


Description:
Power Calculation Procedure for Synchrony AIOL, VI 15


Description:
Final Inspection of Lens Injector Assembly


Description:
Pull Test Procedure using the Chatillion tester


Description:
Injector Lens Placement and Angle Measurement


Description:
Power Calculation Procedure for Synchrony AIOL, VI 16


Description:
Power Calculation Procedure for Synchrony AIOL, VI 17


Description:
Synchrony Power Calculation Using IOL Power noLT.xls


Description:
Pre-Sterile Functional Test of Injector w/ Surface Solutions


Description:
Performing MTF Measurements on the MOVIT


Description:
Interferometer Measurement of Aspheric Mold


Description:
Performing Depth of Focus Measurements on the MOVIT with Eye Cell


Description:
Power Calculation Procedure for Synchrony AIOL, VI 18


Description:
Exchanging the Wet Cell and the Eye Cell on the MOVIT


Description:
Template, Inspection, Outer Optic Dia., Bottom Optic Dia., Overall Length


Description:
Template, IR Scan (Typical) MED-6820 Silicone


Description:
Injector Lens Placement & Angle Inspection Overlay


Description:
Mold, Top, 19.5-24.5 Diopter, Inspection Drawing


Description:
Mold, Middle insert, 19.5-24.5 Diopter, Inspection Drawing


Description:
Mold, Bottom, 19.5-24.5 Diopter, Inspection Drawing


Description:
Mold, Top, 19.0-24.0 Diopter, Inspection Drawing


Description:
Mold, Middle (Insert), 19.0-24.0 Diopter, Inspection Drawing


Description:
Mold, Bottom, 19.0-24.0 Diopter, Inspection Drawing


Description:
Mold, Top, 25.0 Diopter (R&D 21) (Inspection Drawing)


Description:
Mold, Middle (Insert), 25.0 Diopter, (R&D 21) (Inspection Drawing)


Description:
Mold, Bottom, 25.0 -28.0 Diopter (R&D 21) (Inspection Drawing)


Description:
Mold, Middle (Insert) 16.0-18.5 D, (Inspection Drawing)


Description:
Mold, Bottom, 16.0-18.5 D, (Inspection Drawing)


Description:
Mold, Bottom, (58000), V9 (19.0-24.5 D) (Inspection Drawing)


Description:
Mold, Top, (58000), V9, (Inspection Drawing)


Description:
Mold, Middle (Insert) (19.0-24.5 D) V10 Inspection Drawing


Description:
Mold, Bottom, (19.0-24.5 D) V10 Insp,Drw


Description:
Mold, Middle (Insert), V11B, Inspection Drawing


Description:
Mold, Top, V11B, Inspection Drawing, (16.0-28.0D)


Description:
0.0725 x 0.1005 Nozzle Gage Pin, Pre-coated


Description:
0.720 x .1000 Nozzle Gage Pin, Post Coated


Description:
Mold, Bottom, V14, 16.0-28.0 D, Inspection Drawing


Description:
Mold, Middle (Insert), V14,16.0-28.0 D, Inspection Drawing


Description:
Mold, Top, V14, 16.0-28.0 D, Inspection Drawing  CANCEL


Description:
Mold, Middle (Insert), V14,19.0-24.5 D, Inspection Drawing


Description:
Mold, Bottom, 16.0-24.5 D, VI 15, Inspection Drawing


Description:
Mold, Middle (Insert), VI 15, 16.0-18.5 D


Description:
Mold, Middle (Insert), VI 15, 16.0-18.5D, Inspection Drawing


Description:
Mold, Top, VI 15,16.0-24.5D, Inspection Drawing


Description:
Mold, Middle (Insert), VI 15, 19.0-24.5 D


Description:
Mold, Middle (Insert), VI 15, 19.0-24.5D, Inspection Drawing


Description:
Mold, Bottom, 25.0-28.0 D, VI 15, Inspection Drawing


Description:
Mold, Middle (Insert), VI 15, 25.0-28.0D


Description:
Mold, Middle (Insert), VI 15, 25.0-28.0D, Inspection Drawing


Description:
Mold, Top, VI 15, 25.0-28.0D, Inspection Drawing


Description:
Injector Nozzle Rail Flash Removal Fixture


Description:
Injector Plunger Tip Flash Removal Fixture


Description:
Mold, Bottom, 16.0-24.5D,VI 16, Inspection Drawing


Description:
Mold, Middle (Insert),VI 16, 16.0-18.5D, Inspection Drawing


Description:
Mold, Middle (Insert),VI 16, 19.0-24.5D, Inspection Drawing


Description:
Mold, Top, 16.0-24.5D,VI 16, Inspection Drawing


Description:
Ultrasonic Cleaning Liner - 150ml Beaker


Description:
Micro 90 (Concentrated Cleaning Solution)


Description:
Mold, Middle (Insert),VI 17, 16.0-18.5D, Inspection Drawing


Description:
Mold, Middle (Insert),VI 17, 19.0-24.5D, Inspection Drawing


Description:
Mold, Top, 16.0-24.5D,VI 17, Inspection Drawing


Description:
Syringe Barrel, 10cc - OBSOLETE-Combined with 450-003


Description:
Syringe Piston & Barrel Set, Polyethylene


Description:
Container, Shipper Sterilization Load Modular Grid


Description:
Mixing, Degassing and Storing of Silicone Material for Fab. of VIOL and Silicone Slabs


Description:
Fabrication of Visiogen Accommodating Intraocular Lens


Description:
Optical Inspection Procedure of the VAIOL on the Movit


Description:
Labeling Procedure     OBSOLETE   SEE 500-011


Description:
Cleaning Procedure for Lens Carrier Parts


Description:
Cleaning Procedure for Synchrony Injector Nozzle & Slide Comp.


Description:
Injector Components Inspection, Preparation and Rework Process


Description:
Mixing, Degassing, and Storing of Silicone Material (UVAM UV Material)


Description:
Cleaning Procedure for Lens Liner & Lens Tray


Description:
Tumbling Procedure for VAIOL Model VI 16 - OBSOLETE


Description:
Mixing and Storing of Hydrophillic Coating Material for Coating of Injector Components


Description:
Coating Procedure for Synchrony Injector Nozzle & Slide Components


Description:
Final Cleaning & Packaging of VAIOL, VI 16


Description:
Injector Components Inspection, Preparation & Rework Procedure, VI 16


Description:
Coating Procedure for Synchrony Injector Nozzle - Stiped Coating


Description:
Coating Procedure for Synchrony Injector Slide


Description:
Fabrication of Ultem 1000 Mold Tool Blank Bottom


Description:
Fabrication of Ultem 1000 Mold Tool Blank Top


Description:
Fabrication of Ultem 1000 Mold Tool Blank Insert


Description:
Fabrication of Ultem 1000 Mold Tool Bottom


Description:
Fabrication of Ultem 1000 Mold Tool Insert


Description:
Fabrication of Ultem 1000 Mold Tool Top for Aspherical Lens


Description:
Optical Inspection Procedure of the VAIOL on the Movit, V18


Description:
Selection of Investigators and Clinical Sites


Description:
Adverse Events and Adverse Device Effects


Description:
Computer System Security & Disaster Recovery


Description:
Lens, Visiogen Accommodation, 9.8mm X 9.5mm     CANCEL


Description:
Label, For Investigational Use Only, Clear


Description:
Pre-coating Injector Components Transport Bag


Description:
Post Coating Injector Components Transport Bag


Description:
Crosslinker A - OBSOLETE - SEE 600-036-002


Description:
Crosslinker B - OBSOLETE - SEE 600-036-003


Description:
External Process Challenge Device (EPCD)


Description:
Label, 1/4" Dark Blue Circle, Avery #05793


Description:
Nozzle, Striped Coating Zones for 625-001


Description:
Nozzle, Striped Coating Zones for 625-025


Description:
Label, Investigational / Device, English/French To be used by Qualified Inv,Only


Description:
Label, Caution-Investigational device. Limited by Federal Law to investigational use


Description:
Label, Injector Box, Back, CE Mark - OBSOLETE


Description:
Label, Product Identification, CE Mark Version - OBSOLETE


Description:
Label, Injector Box, CE Mark  -  OBSOLETE


Description:
Lens, Final Assembly, R&D 17-V12 (19.0D)


Description:
Lens, Final Assembly, R&D 18-V12 (20.0D)


Description:
Lens, Final Assembly, R&D 19-V12 (21.0 D)


Description:
Lens, Final Assembly, R&D 20-V12 (22.0 D)


Description:
Lens, Final Assembly, R&D 15, V12, (23.0 D)


Description:
Lens, Final Assembly, R&D 16, V12, (24.0 D)


Description:
Lens, Final Assembly, R&D 29, V12, (19.5D)


Description:
Lens, Final Assembly, R&D 30, V12, (20.5 D)


Description:
Lens, Final Assembly, R&D 31, V12, (21.5 D)


Description:
Lens, Final Assembly, R&D 28, V12, (22.5 D)


Description:
Lens, Final Assembly, R&D 33, V12, (23.5 D)


Description:
Lens, Final Assembly, R&D 34, V12, (24.5 D)


Description:
Lens, Final Assembly, R&D 21, V12, (25.0 D)


Description:
Lens, Final Assembly, R&D 22, V12, (25.5 D)


Description:
Lens, Final Assembly, R&D 23, V12, (26.0 D)


Description:
Lens, Final Assembly, VI 14, 16.0-24.5D, Tabulation


Description:
Lens Injector, Final Assy., (S.S.), 16.0-28.0D, Generic


Description:
Lens Injector, Final Assy., (S.S.), Partial Coating, 16.0-28.0D, Generic


Description:
Generic Lens Injector, Final Assembly, S.S., Full Coating


Description:
Lens Injector, Final Assy., Surface Solution, 19.0-24.5D, VI 17


Description:
Final Assembly, Lens-Injector, V18 (Aspheric)


Description:
Final Assembly, Small Incision Injector (3.4mm)


Description:
Surface Solutions Coating Material, Mixed


Description:
Synchrony Injector Product Requirements Document


Description:
CDM Base System - Clinical Data Management Database System


Description:
CDM Base System-System Validation Protocol


Description:
CDM Base System-System Design Specification


Description:
Visiogen MOVIT System Software Requirement


Description:
Final System Validation Report - Phase I


Description:
Final System Validation Report - Phase II


Description:
Synchrony Injector Small Incision Tip Product Requirement Doc.


Description:
Synchrony Injector Small Incision Product Specifications


Description:
Synchrony Injector Surface Solutions Product Spec.


Description:
Visiogen Synchrony Dual Optic AIOL, Model SYNC-100A (V18)


Description:
Accommodating IOL Design and Development Plan


Description:
Product Development Plan for Synchrony Dual Optic IOL System


Description:
Surface Solutions Coating Material Design & Development Plan for the Visiogen Synchrony Injection System


Description:
Small Incision Synchrony Injector Project Plan


Description:
Product Development Plan for Synchrony Dual Optic IOL System, V17


Description:
Design & Development Plan for Synchrony Dual Optic AIOL Model SYNC-100A, V18


Description:
Risk Management System Top Down Analysis


Description:
Cleanroom Cleaning Record    -     OBSOLETE


Description:
New Employee Review List/Termination Checklist


Description:
Quality System Manual Employee Acknowledgement See Form-006


Description:
Classification of Medical Devices & Accessories


Description:
Conformity Assessment Procedure for Medical Devices


Description:
Axial Compression Force Data Recording Sheet


Description:
Preventative Maintenance Log For Mold Clamps


Description:
Lens Location In Fatigue Test Recording Sheet


Description:
Pouch Seal Strengh Form  -  CANCEL - SEE FORM-100


Description:
Mold - Middle (Insert) Visual Inspection


Description:
Visiogen Speedaire Air Compressor Maintenance Schedule


Description:
Visiogen Ingersol Rand Air Compressor Maintenance Schedule


Description:
Visiogen Bransonic Ultrasonic Cleaner Maintenance Schedule


Description:
Visiogen Tray Sealer Maintenance Schedule


Description:
Software & Computer Based System Risk Analysis


Description:
Mold Tooling 1st Article Inspection Request


Description:
Injector Parts Receiving Inspection Router - Nozzle, Injector


Description:
Injector Parts Receiving Inspection Router - Slide, Injector


Description:
Injector Parts Receiving Inspection Router - Clip, Injector


Description:
Injector Parts Receiving Inspection Router - Base, Injector


Description:
Injector Parts Receiving Inspection Router - Cover, Injector


Description:
Injector Parts Receiving Inspection Router - Cap, Injector


Description:
Injector Parts Receiving Inspection Router - Wedge Plate


Description:
Injector Parts Receiving Inspection Router - Plunger, Injector


Description:
Injector Parts Receiving Inspection Router - Coating Zones, Nozzle


Description:
Injector Parts Receiving Inspection Router - Coating Zones, Slide


Description:
Injector Parts Receiving Inspection Router-Base, Injector, Pad Printing


Description:
Test Report Seal Strength of Visiogen Package


Description:
Injector Components Rework and/or Cleaning Log


Description:
Injector Part Receiving Inspection Router, Coating Zones, Nozzle


Description:
Injector Part Receiving Inspection Router, Coating Zones, Slide


Description:
Post Sterilization Inspection Report - Final Assembly


Description:
Inspection Report-Coated Components Lot Release


Description:
Surface Solutions Coating Preparation   Canceled


Description:
Injector Press II - Preventative Maintenance Log


Description:
Injector Part Inspection Router, Coating Zones, Slide, 625-017


Description:
Injector Part Inspection Router, Coating Zones, Nozzle, 625-019


Description:
Refractive Index and Compensator Data Sheet


Description:
Surface Solutions Material Inspection Form


Description:
Complaint Evaluation and Technical Analysis


Description:
Adverse Event Determination and Assessment


Description:
Preventive Maintenance Log - Semi-Automatic Injector Press


Description:
Production and Post Production Evaluation


Description:
Visiogen DI Water Maintenance Schedule (I.D. 0264)


Description:
Surface Solutions Mixing & Coating Log Sheet


Description:
V15 Mold Machining Operations-Progream Numbers


Description:
Mold Top, Aspherical - Inspection Data Sheet


Description:
Sanitizing the Water System-Filters in Place


Description:
Vacuum and Nitrogen Pressure Monitoring Log


Description:
VISIOGEN SYNCHRONY IOL SYSTEM (V15 LENS WITH INJECTOR)


Description:
Visiogen Synchrony Accommodating IOL System (Lens and Injector)


Description:
V18 Lens Design Difference from V15 Lens Design


Description:
Risk Management Plan-Visiogen Synchrony IOL System (Model-SYNC-100A)


Description:
QSM, SOP, WI, MAP, Protocol & Report Preparation


Description:
Cleanroom Requirements, Restrictions, and Guidelines


Description:
Receiving, Inspection and Testing of Silicone Raw Material - OBSOLETE 1/6/06


Description:
Validation of Software & Computer Based Systems


Description:
"A", "X", and Deviation Documentation Release


Description:
Document Control New DCO and DCO Release


Description:
Environmental Monitoring of Product and CEA Area


Description:
Evaluation of Manufacturing and Facility Equipment


Description:
Dimensional Inspection of VAIOL   SUPERCEDED BY 250-002


Description:
Cleaning & Disinfecting of Return Lenses


Description:
Field Safety Corrective Action Procedure (Vigilance System)


Description:
CE Marked Product - Classification and Conformity Assessment-Obsolete


Description:
Incident Reporting Procedure (Vigilance System)


Description:
Mold - First Article Inspection and Release


Description:
Ultem 1000 Visiogen Molds and Inserts Fabrication Process


Description:
Preventive Maintenance Procedure for Mold Clamps


Description:
Procedure for Using Acceptance Sampling Plan


Description:
Receiving, Inspection & Testing of Silicone Raw Mtaerial


Description:
Receiving, Inspection and Testing of Coating Raw Material


Description:
VAIOL Ultem 1000 Mold Tooling Fabrication, Inspection & Release Process Overview, V18


Description:
Cleaning of Cleanroom A, Cleanroom B & the Gowning Room


# tblEmployees

Title:
Director Global Marketing & Bus Development


# tblMaterials

Description:
Case Cover, "in" the Words of the Surgeon


Description:
Jewel Case Cover, In the Words of the Surgeon


Description:
Label, For Investigational Use Only, Clear


# tblNonConformances

Action:
Test run. Product to be use in clinical Build


Action:
R&D drawing to be revise after CA is complete


Action:
mold irregularity will be corrected after clinical unit inventory build-up


NCDesc:
Flash on tip S/B none & gouge on datum B-

Action:
Visual defect was review with mold supplier


Action:
This lot for coating qualifications activities


NCDesc:
Flash on tip S/B none & Bubble & particulates


Action:
Defect does not affect form fit or function of the part


NCDesc:
Damage tip & O/S flash @ .0112" S/B .010" max.

Action:
Will re-work. Refer to re work procedure


Action:
Rework procedure and drawing has been revised to reflect the limit conditions


NCDesc:
Flash, void material, Damage nozzle entrance

Action:
Drawing to be revise to add defect requirements


Action:
Rework procedure to be written as part of the MFG. Process


Action:
Not required. Inspection was done on mfg. To expedite the build


Action:
Revise the drawing to reflect the change


NCDesc:
Mold thickness over size @ 14.05-14.13 S/B 13.97+/- .005mm

Action:
No change, no affect to form fit or function to the lens. Over all mold thickness is acceptable


Action:
Revise the drawing to reflect this change. All the nonconformance's in non functional area


Action:
Revise the drawing to allow embedded bubbles


Action:
First occurrence consider random. Acceptable as is due to +/- .05 tolerance and also passed dimensional and functional test


NCDesc:
Flash & rough bevel tip . S/B no flash and smooth bevel tip


NCDesc:
Failed Bioburden test @ 476CFUs S/B </= 100CFUs

Action:
The test result are considers "Bioburden Spike"  CAPA was signed to investigate this problems CAPA# 016


Action:
Supplier meeting was held & revise inspection set-up & implemented


Action:
Isolated occurrence Supplier was notified


NCDesc:
Water sample exceeded the USP limits for conductivity

Action:
Revise WI-005 to specify only LAL Pyrogen to be test


Action:
Lab testing was preformed for the grease & acceptable, Flash in none-functional area


Action:
Drawing to be revise to add cleaning step


Action:
Condition of existing mold will yield flash. Rework procedure has been revised


Action:
Notified vendor and add process audit to vendor


Action:
Revise drawing to allow embedded particulate


Action:
Supplier will be notified of this occurrences to eliminate in the future


Action:
Process audit will be conducted at the supplier


Action:
Flash is in the non critical area, drawing to be revise to have nominal to be at .040"


Action:
Drawing to be revise to allow embedded particulate


Action:
Products to be machine part within specification on the drawing


Action:
Training was perform to vendor set-up inspection


NCDesc:
Finger print, coating 70%, smear coating


NCDesc:
Coating splashed & missing/ partial coating


Action:
Supplier will be notified as NCR 05-072, 05-073


Action:
Notify supplier and request corrective action


Action:
Revised cleaning solution and P.M on Arbor press


Action:
Notify supplier and request  and obtain corrective action


Action:
Notify Supplier and revised Dwg. To add additional inspection along the  rail.


Action:
Drawing has been revise to coating both sides of the slide


Action:
UAI No impact on Performance ref. DCO# 0728


Action:
Rework gate with new fixture. Revise drawing to add allowance of the gate


NCDesc:
Pierced on Haptic Apex/Flash on fluid channel


Action:
Supplier has been notified of short shot


NCDesc:
Over Size Gate / Lamination and Edge short fill


Action:
Supplier has been notified and to provide C/A


Action:
Lens # 1 will fatigue test for information purposes. No coating relate no C/A


Action:
Mark on the injector pin area has no impact to form fit & function . Will notify vendor for improvement. No C/A


Action:
No production relate. Increase air flow in the clean room by opening vent also reset to activate AC unit.


NCDesc:
1-over size flash, 2-Damage, 3-Part does not match drawing, no notch S/B notch

Action:
Item#-1 UAI for rework procedure Item#-2 UAI Vendor corrected Item#-3 Drawing to be revise to eliminate notch from drawing.


Action:
vendor has been notified, UAI no affect to form fit and function of the assembly


NCDesc:
Cleanroom-2 Location #1 RCS Airstrip result "confluent Growth" @ 5-days incubation.

Action:
C/A not required. The initial test result is considered an random isolated spike. The cause is undetermined at this time.


Action:
CD cover are correct. Drawing must be revise


NCDesc:
PH Failed on Vendor cert. & in-house test

Action:
Vendor will revise pH from 7.5-9.0 to 7.5-9.5. vendor spec. was tighter then material supplier


NCDesc:
cleaned coated nozzle with IPA per Map 500-014 Rev.B,

Action:
Map500-014 Rev, B has been change to clean with water only per Rev. C


NCDesc:
Cleanroom 1 & 2 exceeded recommended temperature above 82°

Action:
Install lock cover over the thermostat to prevent personnel from changing the tem. Setting


NCDesc:
Set point of oven controller was observed 150° C on 10/31/07 S/B 153° C

Action:
Created Log to record oven tem. Revise MAP500-002  and trained operators


Action:
The environment review log form-018 implemented in clean room-2 to check & record term & RH reading


Action:
Static to static out of spec. low. Incorrect red line dim. Due to the Cad software glitch. NCR was cancelled


Action:
Does not affect form fit or functional of the part. Drawing to be revise to add recess.


NCDesc:
Recess machine did not match Drawing  & added operation anneal machined molds at 200 C for 4 HR not showing on WI-024

Action:
Does not affect form fit or functional of the part. Drawing to be revise to add recess. Annueal @ 200 C discontinued


Action:
Measurement was done on in-correct location NCR Cancelled


NCDesc:
Expired calibration, feeler gauge was Used for final inspection


NCDesc:
Injector # 22 High force, Lens Tear posterior spring

Action:
Use As Is not related to Coating CAPA has been open


NCDesc:
Recess machined on back surface of mold near note:4 not showing on drawing

Action:
no affect to form fit & function. Drawing to be revise to include the recess feature


NCDesc:
Deviating from BOM item#6  using un-printed base should be printed

Action:
the use of  un-printed base has no effect to the function and performance of the delivery system. Drawing will be revise to combine printed and un-printed base


NCDesc:
Lens appear "Yellow" tinted color should appear clear.

Action:
Under investigation for yellow lens CAPA# 08-005


NCDesc:
Mixed coating appears clear and has small white particulates

Action:
Scrapped material to vendor for analysis. CAPA assigned 08-003


NCDesc:
Failed post inspection, lens tear and optical inspection

Action:
Under investigation. Assigned CAPA# 08-005


NCDesc:
Start-up MFG. processing of injector component prior to facility Validation

Action:
The process are low risk, manual operations that do not involve facility equipments.


NCDesc:
Mixed Coating appears clear and has small white particulates

Action:
Scrapped material to vendor for analysis. Ref. to  CAPA 08-003


NCDesc:
NCR initiated to remeasure the adopter power on previously

Action:
the work orders list with NCR. Ref. to CAPA 08-004


NCDesc:
Filed in-house viscosity Spec. per form-061

Action:
since these material lots can be mixed molded and meet the other requirements specifified in wi-029


NCDesc:
Incorrect chart replacement, Dickson Model C473 have been used to verify oven compliance (Oven ID# 0008, 0234)

Action:
Replacement paper have been deemed acceptable and all employee who change chart recorder have been trained


NCDesc:
Cleanroom A chart ID# 0061 located on component rack, from 08/25 to 09/02/08 and 08/04-08/11/08 indicated that humidity was above spec.

Action:
No affect to cleanroom A process area since humidity above 70% occurred non-production hour and all work is done within laminar flow bench.


NCDesc:
During CAPA Investigation found suspect of yellow lens


NCDesc:
Pressure differential between cleanroom A and gownroom fail to below spec. .001


NCDesc:
4th quarter environmental monitor for air borne particulate and microbial monitoring. ACM found RCS slide in location 14 contained white mold


NCDesc:
ACM Log for cleanroom A and B did not document type of disinfectant solution use for cleaning


NCDesc:
4th quarter DI water test for conductivity exceeded the USP limits

Action:
Root cause is with NAMSA new sample was sent and pass the tast


NCDesc:
Uncheduled work was performed to expand compressed air line network that also supplies cleanroom A and B


NCDesc:
ACM report dated 09/09/08 states pressure differantial between cleanroon B and gownroon fail below spec. .001


NCDesc:
Di water test done by ACM for Bioburden show 1 CFU with 70mm in diameter


# tblPOMaster

Comments:
returned S8282, S7907;  shippped in two parts items 7,8 and 1-6


Comments:
missing one of PN1705017 Tween20, called and resend 12/10/08 - arrived 12/12/08


Comments:
Returned for Cal 12/15/08  -  RMA#121508BH-1


