BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE

Description of Event or Problem

A SURGEON REPORTED THAT 1 DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS) OF A PATIENT ENDOPHTHALMITIS OCCURRED IN THE OPERATED EYE. AT THE ONE-DAY POST OP SLIT LAMP FINDINGS THE SURGEON NOTED HYPOPYON, AC CELLS AND FLARE, A DECREASE IN PATIENTS BCVA. INITIAL TREATMENT CONSISTED OF TOPICAL MOXIFLOXACIN AND PREDNISONE ACETATE. TWO DAYS AFTER THE INITIAL PROCEDURE THE PATIENT HAD AN ELEVATED IOP OF 36MMHG. THREE DAYS AFTER THE LENS WAS INITIALLY PLACED A VITRECTOMY WAS PERFORMED. CULTURE AND SENSITIVITY PERFORMED WAS POSITIVE FOR ENTEROCOCCUS FAECALIS. INTRAOCULAR INJECTIONS WITH AN UNSPECIFIED MEDICATION WERE ADMINISTERED FOR ENDOPHTHALMITIS TREATMENT ON POSTOPERATIVE DAY 5 AND POSTOPERATIVE DAY 7 FOLLOWING THE ORIGINAL IOL PLACEMENT. AT THE TIME OF REPORTING, THE PATIENT¿S PROGNOSIS AND ONGOING TREATMENT COURSE WERE DESCRIBED AS GOOD.

Additional Manufacturer Narrative

THE DEVICE WAS DISCARDED PER THE REPORTER AND THEREFORE NOT AVAILABLE FOR EVALUATION. A REVIEW OF DEVICE HISTORY RECORD (DHR) DID NOT FIND ANY NON-CONFORMITIES OR ANOMALIES RELATED TO THE REPORTED EVENT. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS, AND DIRECTIONS FOR USE ARE CONSIDERED ACCEPTABLE WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. BAUSCH + LOMB WILL CONTINUE TO MONITOR FOR SIMILAR OCCURRENCES.