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 A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT, THE INNER CYLINDER RODE OVER THE INTRAOCULAR LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SURGEON DID NOT REPORT ANY IOL DAMAGE CAUSED BY THE FAILURE OF THE COMPANY¿S INJECTOR.