CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR

Description of Event or Problem

A PHYSICIAN REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS OBSERVED ON THE POSTERIOR SIDE OF THE LENS AFTER IMPLANTED. THE LENS WAS NOT REMOVED AND REMAINED IMPLANTED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM. ACCORDING TO THE SURGEON, SOMETHING PHYSICALLY SCRATCHED THE POSTERIOR SIDE OF THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

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.