TECNIS ITEC PRELOADED 1-PIECE IOL
Report
- Report Number
- 2648035-2021-00008
- Event Type
- Malfunction
- Date Received
- January 29, 2021
- Report Date
- July 28, 2021
- Manufacturer
- JOHNSON & JOHNSON SURGICAL VISION, INC.
- Product Code
- HQL
- PMA / PMN Number
- P980040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
CORRECTED DATA: THIS REPORT IS TO CORRECT THE INITIAL VMSR 2648035-2021-00008. SECTION B5 INITIALLY REPORTED <NOE> 54 </NOE> EVENTS. CORRECTING THE NUMBER OF EVENTS FROM <NOE> 54 </NOE> TO <NOE> 34 </NOE> EVENTS. THE REMAINING 20 EVENTS WILL BE SUBMITTED AS INDIVIDUAL INITIAL MDRS. BASED ON THE REPORTED INFORMATION, 34 EVENTS MEET THE CRITERIA FOR A SINGLE MALFUNCTION CODE (1069). HAPTIC DETACHED AND HAPTIC DAMAGED ARE CONSIDERED LENS DAMAGED AND ARE CODED AS (1069). THE IOL IS COMPRISED OF THE OPTIC AND HAPTICS WHICH IS A SINGLE DEVICE. THE REMAINING 20 EVENTS CONTAIN OTHER ANCILLARY DETAILS IN ADDITION TO THE MALFUNCTION CODE (1069). THEREFORE, THESE 20 EVENTS WILL BE SUBMITTED AS INITIAL INDIVIDUAL MDRS. REFER TO LIST BELOW FOR THE 20 AFFECTED SERIAL NUMBERS: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.
ADDITIONAL INFORMATION: THERE ARE 3 INVESTIGATIONS COMPLETED DURING THIS PERIOD. BREAKDOWN OF 3 INVESTIGATIONS WITH RESPECTIVE SERIAL NUMBERS ARE AS FOLLOWS: (B)(6) NO PRODUCT RETURNED. (B)(6) LENS CUT. (B)(6) FOREIGN MATERIAL - LOOSE. THE INVESTIGATIONS CONCLUDED THAT PRODUCT MET MANUFACTURING RELEASE CRITERIA AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. THAT WAS RECEIVED DURING THE TIME PERIOD THAT COVERS THIS VOLUNTARY MALFUNCTION SUMMARY REPORT HAS BEEN SUBMITTED.
ADDITIONAL INFORMATION: THERE WAS 1 INVESTIGATION COMPLETED DURING THIS PERIOD FOR SERIAL NUMBER (B)(6). THE PRODUCT WAS RETURNED. THE DEVICE EVALUATION IS AS FOLLOWS: DEVICE EVALUATION: THE CARTRIDGE COMPONENT WAS OBSERVED CORRECTLY ENGAGED INTO THE PCB00 UNIT. VISUAL INSPECTION USING MAGNIFICATION WAS PERFORMED. THE LENS WAS OBSERVED STUCK AT THE CARTRIDGE TUBE. THE ROD TIP IS MAKING CONTACT WITH THE TRAILING HAPTIC. NO RESIDUES OF LUBRICANT WERE DETECTED IN THE CARTRIDGE. DURING SAMPLE EVALUATION, WE ATTEMPTED TO REMOVE THE LENS TO VERIFY LENS DAMAGED. HOWEVER, IT WAS DIFFICULT TO REMOVE THE IOL FROM THE CARTRIDGE. THE REPORTED ISSUE COULD NOT BE VERIFIED. THERE IS NO EVIDENCE TO SUGGEST THAT THE COMPLAINT SAMPLE HAS BEEN AFFECTED BY THE MANUFACTURING PROCESS. THE UNIT WAS HANDLED AND USED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT THREE ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER. THE THREE COMPLAINTS WERE CONFIRMED TO NOT BE RELATED TO MANAUFACTURING PROBLEMS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
ADDITIONAL INFORMATION: THERE ARE 17 INVESTIGATIONS COMPLETED DURING THIS PERIOD. BREAKDOWN OF 17 INVESTIGATIONS WITH RESPECTIVE SERIAL NUMBERS ARE AS FOLLOWS: (B)(6); NO PRODUCT RETURNED. (B)(6); NO PRODUCT RETURNED. (B)(6); NO PRODUCT RETURNED. (B)(6); HAPTIC DETACHED, LENS DAMAGED. (B)(6); CARTRIDGE TIP CRACKED/DAMAGED, OVERRIDE, STUCK IN CARTRIDGE. (B)(6); NO ISSUES IDENTIFIED. (B)(6); CARTRIDGE TIP CRACKED/DAMAGED, OVERRIDE, STUCK IN CARTRIDGE. (B)(6); LENS CUT. (B)(6); NO ISSUES IDENTIFIED. (B)(6); HAPTIC DETACHED. (B)(6); NO PRODUCT RETURNED. (B)(6); NO PRODUCT RETURNED. (B)(6); OVERRIDE, STUCK IN CARTRIDGE. (B)(6); NO PRODUCT RETURNED. (B)(6); LENS CUT . (B)(6); NO PRODUCT RETURNED. (B)(6); LENS CUT,HAPTIC DETACHED. THE INVESTIGATIONS CONCLUDED THAT PRODUCT MET MANUFACTURING RELEASE CRITERIA AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. THAT WAS RECEIVED DURING THE TIME PERIOD THAT COVERS THIS VOLUNTARY MALFUNCTION SUMMARY REPORT HAS BEEN SUBMITTED.
THIS REPORT SUMMARIZES <NOE> 34 </NOE> MALFUNCTION EVENTS RELATED TO LENSDAMAGED. A REVIEW OF EVENTS INDICATED THAT THE IOL MODEL PCB00 EXPERIENCED LENS DAMAGED.
BREAKDOWN OF 54 EVENTS IS AS FOLLOWS: CARTRIDGE CRACK: 1. CARTRIDGE CRACK, DEVICE ADVANCEMENT ISSUE, PLUNGER ROD ISSUE: 1. COSMETIC ISSUES: 5. COSMETIC ISSUES, DEVICE ADVANCEMENT ISSUE: 1. COSMETIC ISSUES, DEVICE PARTIALLY DELIVERED: 1. COSMETIC ISSUES, DEVICE PARTIALLY DELIVERED, PLUNGER ROD ISSUE, STUCK IN CARTRIDGE: 1. COSMETIC ISSUES, FOREIGN MATERIAL - LOOSE: 1. COSMETIC ISSUES, OVERRIDE: 1. COSMETIC ISSUES, STUCK IN CARTRIDGE: 1. COSMETIC ISSUES, UNFOLDING ISSUE: 1. DELIVERY ISSUE, DEVICE PARTIALLY DELIVERED, LENS DAMAGED: 1. DEVICE PARTIALLY DELIVERED, HAPTIC DAMAGED: 2. DEVICE PARTIALLY DELIVERED, HAPTIC DAMAGED, HAPTIC DETACHED: 1. FOLDING ISSUES, HAPTIC DAMAGED: 1. HAPTIC DAMAGED: 12. HAPTIC DETACHED: 11. IOL TORN, LOADING ISSUES, STUCK IN CARTRIDGE: 1. LENS DAMAGED, 11. UNIQUE IDENTIFIER (UDI#): ONLY A PORTION OF THE UDI IS PROVIDED. (B)(4). 36 INVESTIGATION WERE COMPLETED, AND 18 INVESTIGATIONS ARE PENDING FROM THIS PERIOD. (B)(4) NO PRODUCT RETURNED. (B)(4) NO ISSUES IDENTIFIED. (B)(4) CARTRIDGE CRACK, IOL TORN. (B)(4) IOL TORN, STUCK IN CARTRIDGE, (B)(4). HAPTIC DETACHED ,(B)(4). NO PRODUCT RETURNED (B)(4). NO PRODUCT RETURNED (B)(4). NO PRODUCT RETURNED (B)(4). LENS CUT, HAPTIC DETACHED (B)(4). NO PRODUCT RETURNED (B)(4). NO ISSUES IDENTIFIED (B)(4). NO PRODUCT RETURNED (B)(4). NO PRODUCT RETURNED (B)(4). LENS CUT, HAPTIC DETACHED (B)(4). LENS CUT, HAPTIC DETACHED (B)(4). NO PRODUCT RETURNED (B)(4). LENS CUT, HAPTIC DETACHED (B)(4). NO PRODUCT RETURNED (B)(4). NO PRODUCT RETURNED (B)(4). OVERRIDE (B)(4). NO PRODUCT RETURNED (B)(4). NO PRODUCT RETURNED (B)(4). OVERRIDE, STUCK IN CARTRIDGE (B)(4). NO ISSUES IDENTIFIED UNKNOWN NO PRODUCT RETURNED. (B)(4) NO ISSUES IDENTIFIED. (B)(4) NO PRODUCT RETURNED. (B)(4) NO PRODUCT RETURNED. (B)(4) NO PRODUCT RETURNED. (B)(4) NO PRODUCT RETURNED. (B)(4) NO PRODUCT RETURNED. (B)(4) NO PRODUCT RETURNED. (B)(4) NO PRODUCT RETURNED. (B)(4) NO PRODUCT RETURNED (B)(4). NO PRODUCT RETURNED (B)(4). NO PRODUCT RETURNED THE INVESTIGATION CONCLUDED THAT THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. A REVIEW OF THE RECORDS RELATED TO THE DEVICE INCLUDING COMPLAINT TREND AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED THEN A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
THIS REPORT SUMMARIZES (NOE) 54 (/NOE) MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 151179 | TECNIS ITEC PRELOADED 1-PIECE IOL | MONOFOCAL IOLS | HQL | JOHNSON & JOHNSON SURGICAL VISION, INC. | PCB00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |