BAUSCH + LOMB INJECTOR SYSTEM HANDPIECE

Additional Manufacturer Narrative

INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

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.