VITAN

Additional Manufacturer Narrative

SECTION A2, A3, A4, AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION B3: DATE OF EVENT: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D4: CATALOG# IS PARTIAL, EXPIRATION DATE, UDI#, SERIAL#: UNKNOWN/NOT PROVIDED. SECTION D6A: IMPLANT DATE: NOT APPLICABLE, AS THE PRODUCT IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: EXPLANT DATE: NOT APPLICABLE, AS THE PRODUCT IS NOT AN IMPLANTABLE DEVICE. SECTION E1: TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED, AND THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED, AND COMPLAINT HISTORY WERE NOT REVIEWED SINCE THE LOT NUMBER IS UNKNOWN. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE SITE HAS IDENTIFIED A BACTERIAL INFECTION AFFECTING THEIR OPHTHALMOLOGY PATIENTS. AT THIS TIME, IT IS NOT KNOWN WHETHER THE INFECTION IS RELATED TO JOHNSON AND JOHNSON'S LENSES, BUT THE HOSPITAL HAS NOTIFIED ALL OPHTHALMOLOGY SUPPLIERS AS A PRECAUTION. THROUGH FOLLOW UP, WE LEARNED THAT A TOTAL OF FIVE PATIENTS WERE AFFECTED BY SUSPECTED ENDOPHTHALMITIS, SPECIFIC DATES BELOW. ALL FIVE PATIENTS WERE TREATED WITH INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS, AND ONE PATIENT ALSO REQUIRED TOPICAL STEROIDS. AS WE CANNOT RULE OUT ANY PRODUCTS, ALL SUSPECT PRODUCTS ARE REPORTED WITH ALL INTERVENTIONS PROVIDED. AT PRESENT THERE ARE NO LONG-TERM EFFECTS ON THE PATIENT'S VISION AND NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED. WE ALSO LEARNED THAT GCB MODEL INTRAOCULAR LENSES (IOL) WERE IMPLANTED, LAMINAR FLOW PHACO TIPS AND TUBING SETS, AND DK9000 WERE USED ON EACH PATIENT. THERE WAS NO DIFFERENTIATION AS TO WHICH PATIENT HAD WHICH SPECIFIC DEVICE AND AS SUCH, ALL FILES WILL REMAIN CODED WITH TOPICAL STEROIDS. ON (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. ON (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. ON (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. ON (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, STEROIDS AND TOPICAL ANTIBIOTICS ONLY. ON (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT IS AGAINST DK9000. UPON FURTHER REVIEW, MDRS ARE BEING SUBMITTED AGAINST DK9000 AS PRODUCT INVOLVEMENT IN THE EVENT CANNOT BE RULED OUT.