TECNIS SIMPLICITY
Report
- Report Number
- 3012236936-2023-01932
- Event Type
- Malfunction
- Date Received
- August 15, 2023
- Date of Event
- July 24, 2023
- Report Date
- January 24, 2024
- Manufacturer
- AMO PUERTO RICO MFG. INC.
- Product Code
- HQL
- UDI-DI
- 05050474636637
- PMA / PMN Number
- P980040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
SECTION A2, A4 AND A5: PER REGULATION EU (B)(4) (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6B - EXPLANT DATE: DOES NOT APPLY - LENS REMAINS IMPLANTED. (B)(6). SECTION H3 - OTHER (81): THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
CORRECTED DATA: UPON FURTHER REVIEW IT WAS NOTED THAT "G4" FIELD FOR THE PMA NUMBER WAS INADVERTENTLY POPULATED WITH P980040 ON THE INITIAL MDR; THE FIELD SHOULD HAVE BEEN LEFT BLANK. THEREFORE, THE INFORMATION IS BEING CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AS PER THE FOLLOWING: SECTION G4: PMA/510(K) NUMBER: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE PRELOADED 1-PIECE INTRAOCULAR LENS (IOL), MODEL DCB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. ADDITIONAL INFORMATION: SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: PRODUCT EVALUATION WAS PERFORMED ON PHOTOGRAPHS PROVIDED BY THE CUSTOMER. THE REPORTED ¿SCRATCH¿ IN THE PHOTOGRAPH LOOKS LIKE A CHIPPED EDGE, A NICK OUT OF THE LENS EDGE. CERTAIN DEGREE OF COSMETIC CONDITIONS AS THE ONE REPORTED IS ACCEPTABLE AS PART OF THE MANUFACTURING PROCESS; HOWEVER, INSPECTION CONDITIONS SUCH AS ILLUMINATION AND MAGNIFICATION ARE CRITICAL WHEN EVALUATING THE ACCEPTABILITY OF COSMETIC CONDITIONS ON THE LENSES. UNFORTUNATELY, WE CANNOT DETERMINE IF THE OBSERVED CONDITION MEETS THE SPECIFICATIONS OR NOT BECAUSE ONLY A PHOTOGRAPH IS AVAILABLE AND NOT THE IOL TO TAKE FURTHER MEASUREMENTS UNDER A MICROSCOPE USING A RETICLE AS ESTABLISHED BY THE PROCEDURE. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. THE COMPLAINT ISSUE OF HAPTIC DAMAGED WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
IT WAS REPORTED THAT A HAPTIC HAD BEEN OBSERVED BEING SCRATCHED DURING IRRIGATION/ ASPIRATION (IA) FOLLOWING THE IMPLANTATION OF THE INTRAOCULAR LENS (IOL). THE OPERATION FINISHED WITH THE IOL IMPLANTED BECAUSE THE SCRATCH WAS NOT LARGE AND THERE WAS NO PATIENT INJURY. THROUGH FOLLOW-UP WE LEARNED THAT THERE WAS NO INJURIES OR COMPLICATIONS. NO OTHER PARTICULAR PROBLEMS WHERE OBSERVED AND THE PRODUCT WAS DISCARDED. THE DIRECTIONS FOR USE WHERE FOLLOWED BY THE PHYSICIAN. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1246817 | TECNIS SIMPLICITY | INTRAOCULAR LENS | HQL | AMO PUERTO RICO MFG. INC. | DCB00V | 05050474636637 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |