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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

Description of Event or Problem

A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DIFFICULTY IN THE OUTPUT OF THE INJECTOR, SO SURGEON DECIDED NOT TO IMPLANT IT IN THE PATIENT AND NOTICED ONCE THE LENS COMES OUT THAT HAPTIC WAS FRACTURED. REPORTER CONSIDERED THAT THE ADVERSE EVENTS PRESENTED MAY BE RELATED TO THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY.