CATALYS SYSTEM

Additional Manufacturer Narrative

CORRECTED DATA: BASED ON FURTHER REVIEW OF THE COMPLAINT FILE, IT WAS NOTED THAT AN INCORRECT DATE (NOV 5, 2014) WAS INADVERTENTLY ENTERED IN SECTION "H4 - DEVICE MANUFACTURER DATE" OF THE INITIAL MEDWATCH REPORT. THIS SUPPLEMENT IS BEING SUBMITTED TO CORRECT THAT INFORMATION. THE FOLLOWING SECTION HAS BEEN UPDATED ACCORDINGLY: SECTION H4: NOV 6, 2014. ADDITIONAL INFORMATION: PRODUCT EVALUATION WAS PERFORMED FOR THIS INCIDENT. NO MALFUNCTIONS WERE FOUND DURING EVALUATION. MANUFACTURING DEFICIENCY WAS NOT IDENTIFIED. SYSTEM MET ALL SPECIFICATIONS PRIOR TO RELEASE. SERVICE DEFICIENCY WAS NOT IDENTIFIED. DESIGN DEFICIENCY WAS NOT IDENTIFIED. NO USER/USAGE DEFICIENCY IDENTIFIED. ASSESSMENTS OF MANUFACTURING, SERVICE, DESIGN, AND USAGE WERE COMPLETED, AND SYSTEM WAS EVALUATED AND IS PERFORMING TO SPECIFICATION. REVIEWS OF LABELING AND RISK MANAGEMENT FILES WERE CONDUCTED, AND NO NEW ISSUES/RISKS WERE IDENTIFIED. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THESE TYPES OF COMPLAINTS. THE REPORTED ISSUE IS AN ANTICIPATED/EXPECTED EVENT FOR CATALYS-U AND DOES NOT REPRESENT A NEW RISK. BASED ON THE LAST ANNUAL RISK MANAGEMENT REVIEW AND ONGOING POST-MARKET SURVEILLANCE ACTIVITIES, THE PROBABILITY OF OCCURRENCE FOR THE REPORTED EVENT REMAINS WITHIN THE RATES ESTABLISHED IN THE PRODUCT RISK MANAGEMENT FILES. NO NEW ISSUES/RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

Description of Event or Problem

CUSTOMER REPORTED AN INCIDENT THAT OCCURRED IN 2024, "DR. (B)(6) PATIENT UNHAPPY WITH RIGHT EYE SURGERY", THE RECORD WAS NOT AVAILABLE IN THE SYSTEM FOLLOWING A DATABASE RESET. POST-OPERATIVE EVENT WAS REPORTED, THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2024 FOR REMOVAL OF RESIDUAL LENS FRAGMENTS. NO FURTHER INFORMATION PROVIDED.

Additional Manufacturer Narrative

SECTION A2, A3, A4, A5 AND A6: UNKNOWN/ NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE DEVICE IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE DEVICE IS NOT AN IMPLANTABLE DEVICE. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

Additional Manufacturer Narrative

CORRECTED DATA: BASED ON FURTHER REVIEW OF THE COMPLAINT FILE, IT WAS NOTED THAT AN INCORRECT DATE WAS INADVERTENTLY ENTERED IN SECTION "SECTION B3. EVENT DATE" OF THE INITIAL MEDWATCH REPORT. THIS SUPPLEMENT IS BEING SUBMITTED TO CORRECT THAT INFORMATION. THE FOLLOWING SECTION HAS BEEN UPDATED ACCORDINGLY: SECTION B3: NOV 8, 2024. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.