BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C

    MDR report key: 22495123 · Received July 14, 2025

    Report

    Report Number
    1119421-2025-01927
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    April 11, 2025
    Report Date
    July 14, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MSS
    PMA / PMN Number
    K112977
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CARTRIDGE WAS NOT RETURNED FOR AN EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. QUALIFIED ASSOCIATED PRODUCTS WERE USED. THE ROOT CAUSE CANNOT BE DETERMINED FOR THE CARTRIDGE COMPLAINT. THE CARTRIDGE WAS NOT RETURNED TO EVALUATION. NOT ENOUGH INFORMATION WAS PROVIDED FOR FURTHER INVESTIGATION OF THE CARTRIDGE. IT IS UNKNOWN IF ADEQUATE VISCOELASTIC WAS USED IN THE CARTRIDGE. THE INSTRUCTIONS FOR USE (IFU) INSTRUCTS TO COMPLETELY FILL THE CARTRIDGE WITH OPHTHALMIC VISCOSURGICAL DEVICES (OVD) 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. USE THE COMPANY CARTRIDGE AT OPERATING ROOM TEMPERATURES BETWEEN 18 DEGREE CELSIUS (64 DEGREE FAHRENHEIT) AND 23 DEGREE CELSIUS (73 DEGREE FAHRENHEIT). IMPORTANT: THE PLUNGER SHOULD MAKE INITIAL CONTACT WITH THE CARTRIDGE AT THE RAMP. IN THE EVENT THE PLUNGER DOES NOT CONTACT THE CARTRIDGE AT THE RAMP, DO NOT USE THE HANDPIECE AND CONTACT COMPANY. 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 HALF 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 IFU INSTRUCTS: FOLLOW THE SECTION REGARDING DIRECTIONS FOR USE FOR INFORMATION ON THE MAXIMUM ALLOWED TIME FOR THE IOL 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. FILE WILL BE REOPENED IF NEW INFORMATION OR THE CARTRIDGE SAMPLE IS RETURNED. 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 FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER INSERTION A DEFECT WAS NOTED IN THE CENTER OF THE LENS, SO DOCTOR OPTED TO REMOVE AND REPLACE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH COMPANY SAME LENS MODEL AND DIOPTER. THERE WAS NO PATIENT HARM. IN THE SURGEON¿S OPINION DEFECT IN THE CARTRIDGE CONTRIBUTED TO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678488 MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) MSS ALCON RESEARCH, LLC - HUNTINGTON NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CLAREON ASPHERIC UV ABSORBING IOL.| CLAREON MONARCH IV IOL DELIVERY SYSTEM.| MONARCH II LOADING FORCEPS.| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.