TECNIS SIMPLICITY
Report
- Report Number
- 3012236936-2023-02432
- Event Type
- Malfunction
- Date Received
- September 27, 2023
- Date of Event
- September 5, 2023
- Report Date
- December 21, 2023
- Manufacturer
- AMO PUERTO RICO MFG. INC.
- Product Code
- HQL
- UDI-DI
- 05050474739246
- PMA / PMN Number
- P980040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: OCTOBER 9TH, 2023. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES . DEVICE EVALUATION: THE ALLEGED FOREIGN MATERIAL WAS IDENTIFIED ON A RETURNED SWAB. PRODUCT EVALUATION WAS PERFORMED UNDER MAGNIFICATION. PHOTOGRAPHS PROVIDED BY THE CUSTOMER WERE EVALUATED. FOURIER TRANSFORM INFRARED (FTIR) ANALYSIS RESULTS WERE COMPARED TO THE MANUFACTURING SITE FTIR LIBRARY AND NO RESULTS YIELDED AT LEAST A 0.90 CORRELATION. THE HIGHEST MATCHING MATERIAL WAS ¿N/A1PC ALUMINUM PLATE¿ WITH A 0.677992 CORRELATION. THE MATERIAL DID NOT MATCH ANYTHING IN THE MANUFACTURING SITE LIBRARY PAST THE 0.9 CORRELATION VALUE THEREFORE NO CORRELATION TO MANUFACTURING COULD BE FOUND. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE SIMPLICITY PRELOADED 1-PIECE IOL, MODEL DIB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DIB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
SECTION A2 AND A4: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED, THEREFORE NOT EXPLANTED. SECTION E1 - TELEPHONE NUMBER:(B)(6). SECTION H3 - OTHER (81): THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION AS IT IS STILL IMPLANTED. 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
IT WAS REPORTED THAT FOREIGN MATTER HAD BEEN OBSERVED ON THE LENS DURING THE OPERATION. AFTER THE LENS WAS SECURED WITH BALANCED SALT SOLUTION, THE PROCEDURE CONTINUED WITH THE USE OF OPHTHALMIC VISCOSURGICAL DEVICE (OVD). FOLLOWING IMPLANTATION, FOREIGN MATTER WAS DISCOVERED ADHERING TO THE BACKSIDE OF THE INTRAOCULAR LENS (IOL). SUBSEQUENTLY, IT WAS REMOVED FROM THE EYE USING TWEEZERS AFTER THE APPLICATION OF OVD. THE FOREIGN MATTER WAS DETERMINED TO ORIGINATE FROM THE IOL, AS THE REPORTING PHYSICIAN NOTED ITS ADHERENCE TO THE LENS DURING PLACEMENT IN THE EYE. NO PATIENT INJURIES WERE REPORTED, AND THE PATIENT'S VISUAL ACUITY REMAINED UNAFFECTED. THE LENS REMAINS IMPLANTED AND NO ADDITIONAL INFORMATION WAS RECEIVED. NO FURTHER INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1096246 | TECNIS SIMPLICITY | INTRAOCULAR LENS | HQL | AMO PUERTO RICO MFG. INC. | DIB00V | 05050474739246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |