MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

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 NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS GOT SCRATCHED. ADVANCED IN DELIVERY SYSTEM PLUNGER WENT BETWEEN TWO HAPTICS. PRODUCT WAS GOOD, ADVANCING FAILED WHICH CAUSED THE ISSUE OF POSITION TO COMPROMISE LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE LENS WAS OPENED BY THE CIRCULATOR NURSE AFTER VERIFICATION WITH THE DOCTOR. THE LENS CONTACTED A NON-COMPANY OVD AND WAS NOTED TO BE PRELOADED MIDWAY IN THE COMPANY CARTRIDGE. THE LENS WAS HANDLED BY THE SCRUB TECHNICIAN USING NON-COMPANY FORCEPS, AND THE LENS WAS LIFTED BY THE HAPTIC WITH FORCEPS AND THEN FOLDED WITH STERILE GLOVES USING FORCEPS TO PLACE THE LENS INTO THE CARTRIDGE. THE LENS WAS ADVANCED FURTHER INTO THE CARTRIDGE WITH FORCEPS, WITH THE FORCEPS TIPS CLOSED AND POSITIONED TOWARDS THE WALLS OF THE CARTRIDGE DURING THE PROCESS TO SAFELY ADVANCE THE LENS, AND IT WAS THEN ADVANCED FURTHER WITH THE INJECTOR OR HANDPIECE TO COMPLETE THE PROCESS. THE DOCTOR ADVISED THE TECHNICIAN TO ENSURE THAT THE INJECTOR OR HANDPIECE DID NOT PASS BETWEEN THE HAPTICS AND THE LENS DURING ADVANCEMENT, AS THIS WAS REPORTED TO BE THE REASON THE LENS BECAME SCRATCHED.