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

THE HEALTHCARE FACILITY REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED AFTER ACCIDENTAL RUPTURE OF THE POSTERIOR CAPSULE FOLLOWING ASPIRATION OF THE CRYSTALLINE LENS CORTEX. WHEN THE LENS WAS INJECTED INTO THE EYE IT WAS NOTED THAT THERE WAS A CUT AT THE EDGE OF THE LENS OPTIC AND A HAPTIC WAS MISSING. THE INCISION WAS ENLARGED FOR REMOVAL OF THE LENS, AND SEVERAL CORNEAL SUTURES WERE USED TO CLOSE THE INCISION. AS A SUITABLE LENS WAS NOT AVAILABLE THE PATIENT WAS LEFT APHAKIA.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B4, G3, G6, H2, H6 AND H11. ALTHOUGH REQUESTED, THE DEVICE WAS NOT RETURNED FOR EVALUATION. AS A SERIAL NUMBER FOR THE DEVICE WAS NOT PROVIDED, THE ASSOCIATED DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED. THE 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 COULD NOT BE CONCLUSIVELY DETERMINED. BAUSCH + LOMB WILL CONTINUE TO MONITOR SIMILAR OCCURRENCES.