CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR

Description of Event or Problem

A NURSE REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOT USED DUE TO AN INJECTOR OVERRIDE, UPON INSPECTION THEY NOTICED THAT THE IOL BECAME STUCK IN THE CARTRIDGE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AFTER SWITCHING OUT THE IOL, CARTRIDGE, AND INJECTOR. THE IOL DID NOT ENTER THE EYE, AS THE ISSUE WAS NOTICED DURING LOADING. THE DOCTOR BELIEVES THE ISSUE WAS CAUSED BY A FAULTY INSERTER. ADDITIONAL INFORMATION HAD BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS PATIENT CONTACT, AND IT WAS DUE TO BAD INSERTER.

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.