CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR

Description of Event or Problem

A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THE INJECTOR PLUNGER FAILED TO MOVE THE LENS INTO THE PATIENT'S EYE. THIS WAS THE THIRD USE OF THE COMPANY¿S INJECTOR BY THE SURGEON, AND HE STATED THAT HE NO LONGER TRUSTED IT TO CONTINUE USING IT.

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).