TECNIS ITEC PRELOADED 1-PIECE IOL
Report
- Report Number
- 2648035-2020-00399
- Event Type
- Malfunction
- Date Received
- April 28, 2020
- Report Date
- November 23, 2021
- Manufacturer
- JOHNSON & JOHNSON SURGICAL VISION, INC.
- Product Code
- HQL
- UDI-DI
- 05050474558250
- PMA / PMN Number
- P980040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A RETROSPECTIVE REVIEW OF VMSR EVENTS WAS CONDUCTED AND SOME DISCREPANCIES WERE NOTED WHICH CORRECTIONS ARE BEING COMPLETED. STATED THERE WERE 55 INVESTIGATIONS COMPLETED. THE CORRECT NUMBER IS 56 WHICH INCLUDES SERIAL# (B)(4). BREAKDOWN OF COMPLETED INVESTIGATION: (B)(4) CARTRIDGE TIP CRACKED/DAMAGED. THE INVESTIGATION CONCLUDED THAT THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. 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 ARE 6 INVESTIGATIONS COMPLETED DURING THIS PERIOD. BREAKDOWN OF 6 INVESTIGATIONS WITH RESPECTIVE SERIAL NUMBERS ARE AS FOLLOWS: (B)(4) HAPTIC DETACHED, LENS DAMAGED, OVERRIDE, STUCK IN CARTRIDGE (B)(4) LENS DAMAGED, STUCK IN CARTRIDGE (B)(4) OVERRIDE, STUCK IN CARTRIDGE (B)(4) CARTRIDGE TIP CRACKED/DAMAGED, LENS DAMAGED, STUCK IN CARTRIDGE (B)(4) OVERRIDE, STUCK IN CARTRIDGE (B)(4) CARTRIDGE TIP CRACKED/DAMAGED THE INVESTIGATIONS CONCLUDED THAT PRODUCT MET MANUFACTURING RELEASE CRITERIA AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. CORRECTION: FOLLOW-UP WAS RECEIVED FROM THE CUSTOMER. THEY SENT IN THE COMPLAINT PACKAGE WITH THE CORRECT SERIAL# (B)(4). THE PREVIOUS SERIAL# (B)(4) WAS INCORRECT AND REPORTED IN MDR 2648035-2020-00399. 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 CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F AND G. 4 DATE ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE (B)(4) AND CAPA (B)(4) .
ADDITIONAL INFORMATION: 55 INVESTIGATIONS WERE COMPLETED IN THIS PERIOD. BREAKDOWN OF 55 COMPLETED INVESTIGATIONS: 5691741903 LENS CUT 5893801903 OVERRIDE, STUCK IN CARTRIDGE 2526281906 NO PRODUCT RETURNED 2093131911 NO PRODUCT RETURNED 4359841911 NO PRODUCT RETURNED 5624351903 NO PRODUCT RETURNED 2374611911 OVERRIDE,STUCK IN CARTRIDGE 3187011908 NO PRODUCT RETURNED 5972791909 NO PRODUCT RETURNED 6133501808 NO PRODUCT RETURNED 4221931812 NO PRODUCT RETURNED UNKNOWN NO PRODUCT RETURNED 4625781910 HAPTIC DETACHED,IOL TORN, OVERRIDE, STUCK IN CARTRIDGE 5015801910 NO PRODUCT RETURNED 5016061910 NO PRODUCT RETURNED 2148291811 STUCK IN CARTRIDGE 4349611808 STUCK IN CARTRIDGE 4531111911 NO PRODUCT RETURNED 6098511903 CARTRIDGE TIP CRACKED/DAMAGED 3770201912 STUCK IN CARTRIDGE 5140021906 NO PRODUCT RETURNED 4889681811 NO PRODUCT RETURNED 4116401910 NO PRODUCT RETURNED 5783781909 NO PRODUCT RETURNED 3460361912 NO PRODUCT RETURNED 6139131712 LENS CUT 3034261909 CARTRIDGE TIP CRACKED/DAMAGED 2396711803 LENS CUT, HAPTIC DETACHED 5891371910 LENS CUT 4972281905 LENS CUT,HAPTIC DETACHED 3301362001 NO PRODUCT RETURNED 4129581910 NO PRODUCT RETURNED 3766311908 NO PRODUCT RETURNED 2624722001 HAPTIC DAMAGED,STUCK IN CARTRIDGE 2144631911 STUCK IN CARTRIDGE 5139421906 NO PRODUCT RETURNED 4261861907 NO PRODUCT RETURNED 3803272001 NO PRODUCT RETURNED 3478921912 NO PRODUCT RETURNED 3048392002 NO PRODUCT RETURNED 3064992002 NO PRODUCT RETURNED 5959931910 NO ISSUES IDENTIFIED 4932501907 LENS CUT,DC-HAPTIC DETACHED 3169171911 CARTRIDGE TIP CRACKED/DAMAGED, HAPTIC DAMAGED,HAPTIC DETACHED,STUCK IN CARTRIDGE 4136171905 NO PRODUCT RETURNED 5706021903 NO PRODUCT RETURNED 5196671801 LEAD HAPTIC NOT FOLDED, STUCK IN CARTRIDGE 2120311703 NO PRODUCT RETURNED 2257291706 NO PRODUCT RETURNED 2631961802 NO PRODUCT RETURNED 3988361801 NO PRODUCT RETURNED 2403171812 NO PRODUCT RETURNED 2777261809 NO PRODUCT RETURNED 3125181804 NO PRODUCT RETURNED 4523061804 NO PRODUCT RETURNED THE INVESTIGATION CONCLUDED THAT THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. CORRECTION: IN THE INITIAL REPORT IT WAS INDICATED THAT THERE WERE 124 EVENTS HOWEVER, THE CORRECT NUMBER IS 123 SINCE DURING THIS QUARTER ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ONE OF THE PRODUCTS WITH SERIAL NUMBER 4110201907 DID NOT HAVE A MALFUNCTION AND THEREFORE THE EVENT IS NO LONGER CONSIDERED A REPORTABLE MALFUNCTION. NO FURTHER INFORMATION WILL BE PROVIDED IN REGARD TO THIS DEVICE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
ADDITIONAL INFORMATION: BREAKDOWN OF 124 EVENTS: COSMETIC ISSUES ¿ 11, COSMETIC ISSUES, DEVICE ADVANCEMENT ISSUE ¿ 1, COSMETIC ISSUES, DIFFICULT TO USE, UNFOLDING ISSUE ¿ 1, COSMETIC ISSUES, OVERRIDE ¿ 1, DELIVERY ISSUE, HAPTIC DAMAGED ¿ 1, DEVICE ADVANCEMENT ISSUE, HAPTIC DAMAGED ¿ 1, DEVICE ADVANCEMENT ISSUE, LENS DAMAGED ¿ 3, DIFFICULT TO USE ¿ 1, FOLDING ISSUES, LENS DAMAGED ¿ 1, FOLDING ISSUES, STUCK IN CARTRIDGE ¿ 1, HAPTIC DAMAGED ¿ 23, HAPTIC DAMAGED, PLUNGER ROD ISSUE ¿ 1, HAPTIC DAMAGED, ROD STIFF ¿ 1, HAPTIC DAMAGED, TRAILING HAPTIC NOT FOLDED ¿ 2, HAPTIC DETACHED ¿ 16, IOL TORN ¿ 5, LENS DAMAGED ¿ 49, LENS DAMAGED, STUCK IN CARTRIDGE - 5. SERIAL NUMBERS OF SUSPECT PRODUCTS (B)(4). 67 INVESTIGATIONS WERE COMPLETED, AND 57 INVESTIGATIONS WERE PENDING FROM THIS PERIOD. BREAKDOWN OF 67 COMPLETED INVESTIGATIONS WITH SERIAL NUMBERS ARE AS FOLLOWS: (B)(4). IN ALL THE INVESTIGATIONS IT WAS CONCLUDED THAT PRODUCTS MET MANUFACTURING RELEASE CRITERIA AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILE. 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> 124 </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 |
|---|---|---|---|---|---|---|---|
| 469798 | TECNIS ITEC PRELOADED 1-PIECE IOL | MONOFOCAL IOLS | HQL | JOHNSON & JOHNSON SURGICAL VISION, INC. | PCB00 | 05050474558250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |