BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE

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 AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), THE LENS SUBSEQUENTLY DISLOCATED. APPROXIMATELY SIX WEEKS AFTER ONSET OF THE ISSUE, THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE DISLOCATION WAS CAPSULE DAMAGE. IT IS NOT CLEAR WHEN THE CAPSULE DAMAGE HAPPENED. THE PATIENT¿S OUTCOME IS GOOD.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B4, G3, H2, H11. BASED ON ADDITIONAL INFORMATION RECEIVED, THE DEVICE CAUSALITY WAS ASSESSED AS UNRELATED TO THE EVENT, AND THEREFORE THIS EVENT NO LONGER MEETS REPORTABILITY REQUIREMENTS AND IS NO LONGER DEEMED REPORTABLE.