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 HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE PHACOEMULSIFICATION WITH INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE THE IOL WAS PINCHED IN THE TUNNEL INCISION AND BURST IN THE LATERAL PART OF THE IOL BODY. AT THE SAME TIME, THE WIDTH OF THE INCISION (2.4 MM) CORRESPONDED TO THE WIDTH OF THE CARTRIDGE. GIVEN THIS SITUATION, THE SURGEON DECIDED TO STOP FURTHER IMPLANTATION AND REMOVE THE IOL FROM THE TUNNEL INCISION. THE LENS HAD BEEN REMOVED FROM THE EYE, ANOTHER LENS WAS IMPLANTED. POST THE INITIAL SURGERY THE PATIENT DOES NOT COMPLAIN, OBJECTIVELY THE EYE WAS CALM, VISUAL ACUITY WAS 1.0, THE CORNEA WAS TRANSPARENT, THE ANTERIOR CHAMBER WAS OF MEDIUM DEPTH, THE IOL IN THE CAPSULE BAG WAS TRANSPARENT. THE REFLEX FROM THE FUNDUS WAS PINK.

Additional Manufacturer Narrative

A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT OF A DAMAGED LENS DURING IMPLANTATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE REPORTED PRODUCT¿S LOT NUMBER WAS NOT REPORTED, PREVENTING LOT NUMBER SPECIFIC REVIEWS FOR SIMILAR COMPLAINTS OR NONCONFORMANCES. HOWEVER, BEFORE PRODUCTION RELEASE, EACH PRODUCT HISTORY RECORD IS REVIEWED TO ENSURE THAT ALL ASSOCIATED PRODUCTS MEET THE REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. ONE PHOTO ATTACHED TO THE PARENT COMPLAINT WAS REVIEWED BY THE INVESTIGATION SITE. THE PHOTO SHOWS THREE IMAGES OF THE LENS IN A TRAY. THE LENS IS DAMAGED. THE REPORTED ISSUE WAS CONFIRMED; HOWEVER, HOW THE DAMAGED OCCURRED CANNOT BE DETERMINED FROM THE REVIEW. BASED ON THE EVALUATION OF THE INFORMATION AND PHOTO RECEIVED, THE INVESTIGATION WAS UNABLE TO IDENTIFY THE ROOT CAUSE OR ORIGIN OF THE REPORTED EVENT. WHILE THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, THE FOLLOWING FACTORS OUTLINED IN THE REPORTED PRODUCT¿S INSTRUCTION FOR USE (IFU) COULD POTENTIALLY CONTRIBUTE TO AN OUTCOME SIMILAR TO THE REPORTED EVENT. THE IFU STATES THAT THE HANDPIECE MUST BE INSPECTED PRIOR TO EACH USE TO CONFIRM IT IS FREE OF DAMAGE. IT FURTHER EMPHASIZES THAT IF THE HANDPIECE¿PARTICULARLY THE PLUNGER TIP¿APPEARS DAMAGED, BENT, OR OTHERWISE UNFIT FOR PROPER USE, IT MUST NOT BE USED. IN SUCH CASES, USERS ARE INSTRUCTED TO CONTACT ALCON IMMEDIATELY. THE IFU ALSO PROVIDES A LIST OF QUALIFIED CARTRIDGE COMBINATIONS TO USE. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE IOL AND POTENTIAL COMPLICATION DURING THE IMPLANTATION PROCESS. 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.