SENSAR IOL
Report
- Report Number
- 3012236936-2024-000344
- Event Type
- Malfunction
- Date Received
- December 20, 2024
- Date of Event
- December 11, 2024
- Report Date
- December 20, 2024
- Manufacturer
- AMO PUERTO RICO MFG. INC.
- Product Code
- HQL
- PMA / PMN Number
- P980040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: THROUGH FOLLOW-UP THE CUSTOMER PROVIDED ADDITIONAL DETAILS. THIS CURRENT REPORT IS TO PROVIDE THIS INFORMATION. THE OPERATIVE EYE IS THE RIGHT EYE. THE CUSTOMER ATTEMPTED TO IMPLANT A DIFFERENT IOL THREE TIMES. THE FOURTH ATTEMPT WAS SUCCESSFULLY INSERTED. INFORMATION ON THE ADDITIONAL THREE IOLS SUCH AS THE SERIAL NUMBER OF THE IOLS WAS NOT SAVED AND NOT PROVIDED. WHEN ASKED IF THERE WAS A CAPSULE TEAR OR SUTURES USED, THE CUSTOMER RESPONDED AS "UNKNOWN". WHEN ASKED IF THERE WAS A VITRECTOMY AND IF YES, WAS IT TRIGGERED BY THE JNJ IOL, THE CUSTOMER RESPONDED AS N/A. THE CUSTOMER CLARIFIED THAT FOR THE FIRST IOL SERIAL# (B)(6), THE IOL WAS FULLY INSERTED AND THEN REMOVED AND REPLACED (INITIAL MANUFACTURER REPORT NUMBER. REGARDING THE SECOND IOL, THE SERIAL NUMBER WAS NOT PROVIDED. IT WAS PARTIALLY INSERTED. PRIOR TO BEING FULLY INSERTED, IT WAS IDENTIFIED THAT THE HAPTIC HAD BROKEN OFF (MANUFACTURER REPORT NUMBER 3012236936-2025-0000096). CONSEQUENTLY, THE CUSTOMER ATTEMPTED TO USE A THIRD IOL. FOR THE THIRD IOL, THE SERIAL NUMBER WAS NOT PROVIDED. AFTER BEING FULLY INSERTED, THE HAPTIC BROKE OFF (MANUFACTURER REPORT NUMBER 3012236936-2025-0000097). THE CUSTOMER USED A FOURTH IOL. THIS WAS THE LAST LENS, AND IT WAS SUCCESSFULLY INSERTED, IMPLANTED. THE DOCTOR¿S FULL NAME WAS PROVIDED AS DIANA LIND. THE PATIENT IS A FEMALE WHO WEIGHS 149 POUNDS, AND THEIR DATE OF BIRTH IS (B)(6) 1952. THE SUSPECT IOLS ARE NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED. THIS CURRENT REPORT IS TO PROVIDE THIS INFORMATION. SECTION A2 AGE OR DATE OF BIRTH: (B)(6) 1952. SECTION A3A, SEX: FEMALE SECTION A3B, GENDER: THE CUSTOMER RESPONDED AS ¿FEMALE¿. SECTION A4, PATIENT WEIGHT: 149 POUNDS SECTION E1, TITLE: (B)(6). SECTION E1, FIRST/GIVEN NAME/LAST NAME: (B)(6). SECTION E2, HEALTH PROFESSIONAL? YES SECTION E3, OCCUPATION: PHYSICIAN SECTION H6, HEALTH EFFECT - IMPACT CODE: 4631 USED TO CAPTURE THE REMOVAL AND REPLACEMENT OF THE IOL. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
SECTION A2, A3A, A3B, A4, A5, A6, PATIENT INFORMATION: UNKNOWN/NOT PROVIDED. SECTION D6A, IF IMPLANTED, GIVE DATE: NOT APPLICABLE. THERE IS NO INDICATION THE LENS WAS IMPLANTED. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE. THERE IS NO INDICATION THE LENS WAS IMPLANTED. THEREFORE, IT WAS NOT EXPLANTED. SECTION H3, DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT 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, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) BROKE DURING INSERTION. FOLLOW-UP WAS PERFORMED BUT NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2154846 | SENSAR IOL | INTRAOCULAR LENS | HQL | AMO PUERTO RICO MFG. INC. | AR40E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |