UNK_MONOFOCAL IOL

Additional Manufacturer Narrative

SECTION A2, A3A, A3B, A4, A5, A6: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3: DATE OF EVENT: UNKNOWN/NOT PROVIDED. SECTION D4: MODEL NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: CATALOG NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, AS INFORMATION WAS NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. SECTION D6B: IF EXPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. SECTION E1: TELEPHONE NUMBER: (B)(6) SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION WAS CONDUCTED, HOWEVER, THERE IS NO ADDITIONAL INFORMATION AVAILABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT SURGEONS IN THE OPERATING ROOM (OR) HAVE HAD RECURRING ISSUES WITH THE TECNIS INTRAOCULAR LENSES (IOLS) IN GENERAL AND NOT TIED TO SPECIFIC CASES OVER THE PAST FEW WEEKS. SPECIFICALLY, DURING IMPLANTATION, THE HAPTICS OF THE LENS HAVE REMAINED STUCK TOGETHER DESPITE ADHERENCE TO THE INJECTOR PREPARATION PROCEDURE. THIS HAS REQUIRED SURGEONS TO MANUALLY SEPARATE THE HAPTICS. THERE WAS NO IMPACT ON THE SURGICAL PROCEDURE NOR ON PATIENT SAFETY, HOWEVER, THE SITUATION HAS BEEN BOTHERSOME FOR THE SURGEONS. THROUGH FOLLOW UP, IT WAS CONFIRMED THAT SPECIFICS LENS MODELS WERE NOT AVAILABLE; SEVERAL MODELS WERE IMPLANTED, BUT MOSTLY IOL MODELS ZCU, DIB00, AND DCB00. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR THE UNKNOWN INTRAOCULAR LENS MODEL. SEPARATE REPORTS ARE BEING SUBMITTED FOR THE OTHER LISTED MODELS.