CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR

Description of Event or Problem

A PHARMACIST REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS DID NOT MOVE TO THE CARTRIDGE, AND THE PHYSICIAN TRIED IT TWICE. HENCE THE LENS WAS CHANGED, AND THE SURGERY WAS COMPLETED ON THE SAME DAY. THE NEXT DAY, AGAIN THE SAME ISSUE OCCURRED AND THE REPORTER SUSPECTS INJECTOR TO BE DEFECTIVE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE IMPLANT WAS DAMAGED PRIOR TO INJECTION, DURING THE PASSAGE OF THE INJECTOR PISTON.

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.