CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

Description of Event or Problem

A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SET IN THE INJECTOR AS USUAL AND INSERTED INTO THE EYE, BUT SCRATCHES AND DAMAGE WAS FOUND ON THE INTRAOCULAR LENS. AT THAT TIME, NO HEALTH RISKS HAVE BEEN DETERMINED FROM THE SURGERY. THE SURGERY WAS COMPLETED WITH THE LENS STILL FIXED IN THE BAG. ADDITIONAL INFORMATION HAS BEEN REQUESTED.