BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE

Additional Manufacturer Narrative

ALTHOUGH REQUESTED, THE DEVICE WAS NOT RETURNED FOR EVALUATION. AS A LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, THE ASSOCIATED DEVICE HISTORY RECORD WAS NOT REVIEWED. THE TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT 6 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD) THE PATIENT PRESENTED WITH CLINICAL FINDINGS CONSISTENT WITH ACUTE ENDOPHTHALMITIS ACCOMPANIED BY A DECREASE IN VISUAL ACUITY FROM COUNTING FINGERS AT 4 FEET TO HAND MOTION. THE PATIENT WAS REFERRED THE SAME DAY TO A RETINA SPECIALIST, WHO PERFORMED A CULTURE AND ADMINISTERED AN INTRAOCULAR INJECTION. THE CULTURE SHOWED NO GROWTH. APPROXIMATELY EIGHT WEEKS LATER, THE PATIENT UNDERWENT A PARS PLANA VITRECTOMY TO ADDRESS A POSTERIOR VITREOUS DETACHMENT (PVD). AT THE POSTOPERATIVE VISIT THE FOLLOWING DAY, THE RETINA SPECIALIST DOCUMENTED: RESOLVED ACUTE ENDOPHTHALMITIS WITH STRUCTURALLY STABLE FINDINGS, CENTRAL RETINAL VEIN OCCLUSION WITH MACULAR EDEMA OD, EPIRETINAL MEMBRANE IN BOTH EYES (OU), RESOLVED PVD OD, AND PVD LEFT EYE (OS). IN THE IMPLANTING SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE MOST RECENT RECORDED VISUAL ACUITY FOR THE AFFECTED EYE WAS NO LIGHT PERCEPTION (NLP). THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PREDNISOLONE 1%: 1 GTT QID X 2 WEEKS, THEN TID X 2 WEEKS (TOTAL DURATION: 1 MONTH), OFLOXACIN 0.3%: 1 GTT QID X 7 DAYS, KETOROLAC 0.5%: 1 GTT QID X 2 WEEKS, THEN TID X 2 WEEKS (TOTAL DURATION: 1 MONTH). MEDICATIONS DOCUMENTED AT RETINA VISIT ON (B)(6) 2026: CIPROFLOXACIN: 0.3% 1 GTT QID OD, PREDNISOLONE ACETATE: 1% 1 GTT QID OD, SYSTANE: 1 GTT BID OU.