BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

    MDR report key: 23476238 · Received November 5, 2025

    Report

    Report Number
    1119421-2025-02854
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    September 29, 2025
    Report Date
    December 1, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MSS
    PMA / PMN Number
    K063155
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN D.9., H.3., H.6., AND H.11. TWO PIECES OF THE BROKEN LENS WERE RETURNED ADHERED TO A PIECE OF PAPER IN A ZIPLOCK BAG. THE OTHER PORTION OF THE LENS WAS RETURNED IN THE NOZZLE ENTRY AREA OF A COMPANY III (D) CARTRIDGE. INADEQUATE VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. THE CARTRIDGE HAD EVIDENCE OF PLACEMENT INTO A HANDPIECE. THE TIP HAD MEDIUM STRESS. THE USED COMPANY III (D) CARTRIDGE WAS CLEANED FOR FURTHER EVALUATION. TOP COAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. THE REPORTED PRODUCT LOT NUMBER WAS NOT PROVIDED. LOT SPECIFIC REVIEWS FOR SIMILAR COMPLAINTS OR NON-CONFORMANCES COULD NOT BE CONDUCTED. HOWEVER, BEFORE PRODUCTION RELEASE, EACH DEVICE HISTORY RECORD IS REVIEWED TO ENSURE THAT THE PRODUCT MET THE REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. A QUALIFIED LENS MODEL/DIOPTER AND HANDPIECE WERE INDICATED WITH A NON-QUALIFIED VISCOELASTIC. THE ROOT CAUSE FOR THE LENS DAMAGE MAY BE RELATED TO A FAILURE TO FOLLOW THE IFU (INSTRUCTIONS FOR USE). THERE DID NOT APPEAR TO BE ADEQUATE VISCOELASTIC IN THE CARTRIDGE. IT WAS STATED THE LENS WAS PREPPED AND SET ASIDE. IT IS UNKNOWN HOW LONG THE LENS WAS IN THE DELIVERY SYSTEM BEFORE DELIVERY. IN ADDITION, A NON-QUALIFIED VISCOELASTIC WAS INDICATED. THE IFU INSTRUCTS THAT AN COMPANY QUALIFIED DELIVERY SYSTEM AND VISCOELASTIC COMBINATION SHOULD BE USED. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE LENS AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. THE IFU INSTRUCTS TO COMPLETELY FILL THE CARTRIDGE WITH OVD (OPHTHALMIC VISCOSURGICAL DEVICE) IMMEDIATELY PRIOR TO LOADING AND DELIVERY OF THE LENS. DO NOT ATTEMPT TO LOAD THE LENS WITHOUT ADEQUATE OVD IN THE DEVICE. NOT ADEQUATELY FILLING THE DEVICE WITH VISCOELASTIC WILL RESULT IN INADEQUATE COVERAGE OF LENS AND THE LENS FOLD PATH WITH OVD, WHICH MAY RESULT IN DAMAGE. THE IFU INSTRUCTS: USING HOLDING FORCEPS, GRASP THE LENS BY THE OPTIC EDGE AND GENTLY PLACE THE LENS ANTERIOR SIDE UP INTO THE BACK OF THE OVD-FILLED CARTRIDGE. THE LENS SHOULD BE INSERTED UNTIL THE OPTIC IS A LITTLE MORE THAN HALF-WAY INSIDE THE CARTRIDGE. USE THE HOLDING FORCEPS TO GENTLY PUSH DOWN ON THE LENS, VERIFYING THAT THE LENS IS ON THE BOTTOM SURFACE OF THE CARTRIDGE. USING HOLDING FORCEPS, TAKE THE TRAILING HAPTIC, AND GENTLY FOLD THE HAPTIC ONTO THE ANTERIOR SIDE OF THE OPTIC. SLOWLY GRIP OR PUSH THE OPTIC EDGE TO POSITION THE LENS AS FAR INTO THE CARTRIDGE AS THE FORCEPS WILL PERMIT, WHILE ENSURING THE LENS REMAINS ON THE BOTTOM SURFACE OF THE CARTRIDGE AND THE TRAILING HAPTIC REMAINS ON THE OPTIC. FAILURE TO FOLLOW THESE STEPS MAY CAUSE THE LENS TO ADVANCE INCORRECTLY CAUSING DELIVERY ISSUES AND/OR DAMAGE. THE IFU INSTRUCTS: FOLLOW THE SECTION REGARDING DIRECTIONS FOR USE FOR INFORMATION ON THE MAXIMUM ALLOWED TIME FOR THE IOL (INTRAOCULAR LENS) TO STAY IN THE FOLDED CONDITION. FAILURE TO ADHERE TO MANUFACTURER¿S RECOMMENDATIONS MAY RESULT IN IOL DAMAGE. IFU NOTE: DURING LENS LOADING AND INSERTION, DO NOT ALLOW THE COMPANY IOL TO REMAIN IN A FOLDED CONDITION WITHIN THE SELECTED IOL DELIVERY SYSTEM FOR MORE THAN 3 MINUTES PRIOR TO COMPLETING INSERTION INTO THE CAPSULAR BAG. THE HANDPIECE IFU INSTRUCTS: VERIFY THAT THE PLUNGER TIP IS PROPERLY ENGAGING THE LENS OPTIC AND THAT THE LENS MOVES FORWARD AT THE SAME RATE AS THE PLUNGER WHILE SLOWLY ADVANCING THE PLUNGER FORWARD TO AVOID DAMAGING THE LENS. WHEN THE THREADS ON THE KNOB MAKE CONTACT WITH THE BARREL, TURN THE KNOB CLOCKWISE APPROXIMATELY ½ TURN TO ENGAGE THE THREADS AND THEN STOP. THE IOL WILL NOW BE IN THE DWELL POSITION. INSPECT TO ENSURE THE PLUNGER IS BEHIND THE OPTIC. 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.

    Additional Manufacturer Narrative · 0

    A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. 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 · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS PREPARED FOR IMPLANTATION AND THEN SET ASIDE BY THE SURGEON UNTIL READY FOR USE. THE LENS CAME OUT OF THE CARTRIDGE INTO THE EYE AND WAS MANGLED BY THE INJECTOR. THE LENS WAS THEN CUT OUT. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491450 MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) MSS ALCON RESEARCH, LLC - HUNTINGTON NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female CLAREON PANOPTIX TORIC TRIFOCAL UV IOL| MONARCH III IOL DELIVERY SYSTEM, INJECTOR| VISCOELASTIC: HEALON PRO