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 11 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), THE PATIENT PRESENTED WITH CLINICAL FINDINGS CONSISTENT WITH ENDOPHTHALMITIS. AT THAT TIME, VISUAL ACUITY HAD DECREASED FROM 20/200 TO HAND MOTION. THE PATIENT WAS REFERRED THE SAME DAY TO A RETINA SPECIALIST, WHO DOCUMENTED 1-2 ANTERIOR CHAMBER CELLS, <1MM HYPOPYON, FIBRINOID MEMBRANE AT PUPIL, POSTERIOR SYNECHIAE, AND DENSE VITREOUS OPACITIES. A VITREOUS TAP WAS PERFORMED, AND INTRAVITREAL VANCOMYCIN AND CEFTAZIDIME WAS ADMINISTERED. THE CULTURE SHOWED NO GROWTH. IN THE IMPLANTING SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PREDNISOLONE 1%: 1 GTT QID X 2 WEEKS, THEN BID 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 BID X 2 WEEKS (TOTAL DURATION: 1 MONTH) MEDICATIONS DOCUMENTED AT RETINA VISIT ON (B)(6) 2026: PREDNISOLONE ACETATE: 1% 1 GTT KETOROLAC 0.5%: 1 GTT TID OFLOXACIN 0.3%: 1 GTT QID CYCLOPENTOLATE 1%: 1 GTT TID.