CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR

Additional Manufacturer Narrative

THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE LENS REMAINS IMPLANTED. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED, AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS HAD A CRACK NEXT TO THE HAPTIC. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE SURGEON¿S OPINION THE INJECTOR CAUSED OR CONTRIBUTED TO THE EVENT. THE LENS WAS LEFT IMPLANTED. NO PATIENT HARM OCCURRED.