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 INTRAOCULAR LENS (IOL) IMPLANTATION IN PATIENT'S RIGHT EYE, A SCRATCH WAS OBSERVED ON THE POSTERIOR SIDE OF THE IOL AFTER IT WAS IMPLANTED. THE LENS WAS NOT REMOVED FROM THE EYE, IT REMAINS IMPLANTED. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM. ACCORDING TO THE SURGEON, SOMETHING PHYSICALLY SCRATCHED THE POSTERIOR SIDE OF THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.