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).

Description of Event or Problem

A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR PLUNGER FAILED TO MOVE THE LENS INTO THE PATIENT'S EYE WHILE IMPLANTING. SURGEON OBSERVED THAT THE INJECTOR PLUNGER PASSED OVER THE LENS WITHOUT MOVING IT. SUBSEQUENTLY THE LENS WAS REMOVED AND PLACED BACK IN THE CARTRIDGE, BUT THE SAME THING HAPPENED. GIVEN THE SURGICAL EMERGENCY, SURGEON OPTED TO REMOVE THE LENS FROM THE CARTRIDGE THEN ENLARGED THE INCISION AND IMPLANTED IT MANUALLY, WITH THE INHERENT RISKS AND COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.