BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

    MDR report key: 19132698 · Received April 18, 2024

    Report

    Report Number
    1119421-2024-00745
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    March 20, 2024
    Report Date
    July 12, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MSS
    UDI-DI
    00380659777639
    PMA / PMN Number
    K063155
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION, INDICATED THE PRODUCT MET RELEASE CRITERIA. QUALIFIED ASSOCIATED PRODUCTS WERE INDICATED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE PRODUCT WAS NOT RETURNED. NO DETERMINATION CAN BE MADE WITHOUT PHYSICAL EXAMINATION OF THE PRODUCT. THE INSTRUCTION FOR USE (IFU), INSTRUCTS TO COMPLETELY FILL THE CARTRIDGE WITH OPHTHALMIC VISCOSURGICAL DEVICE (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 DEGREES CENTIGRADE (64 DEGREES FAHRENHEIT) AND 23 DEGREES CENTIGRADE (73 DEGREES FAHRENHEIT). THE HANDPIECE IFU INSTRUCTS: IMPORTANT: THE PLUNGER SHOULD MAKE INITIAL CONTACT WITH THE COMPANY 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. 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 FILE WILL BE REOPENED, IF THE SAMPLE IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    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 · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INSERTION OF THE INTRAOCULAR LENS (IOL), IN AN IMPLANT PROCEDURE, AS THE SURGEON ADVANCED THE LENS WITHIN THE COMPANY CARTRIDGE THE CARTRIDGE BEGAN TO SPLIT LENGTHWISE BEGINNING AT THE TIP THAT CONTACTED THE PATIENT. THE LENS WAS REMOVED AND RE-LOADED INTO A DIFFERENT CARTRIDGE OF THE SAME MODEL. THE PROCEDURE WAS COMPLETED ON SAME DAY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 2 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539658 MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) MSS ALCON RESEARCH, LLC - HUNTINGTON NA 15776526 00380659777639

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ACRYSOF IOL| CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR| DUOVISC VISCOELASTIC SYSTEM