BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH D CARTRIDGE

    MDR report key: 2484414 · Received February 28, 2012

    Report

    Report Number
    2484414
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 28, 2012
    Manufacturer
    ALCON LABORATORIES
    Product Code
    KYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION OF THE INTRAOCULAR CHAMBER LENS IT WAS NOTED THAT THE PREVIOUS EXAMINED AND INTACT CARTRIDGE EXHIBITED UNDUE AMOUNT OF RESISTANCE AND EVENTUALLY BEGAN TO SPLIT WITH RADIAL SPLINTER CRACKS AROUND ITS DISTAL TIP. THE PLASTIC TIP FLARED OPEN ALLOWING THE LENS TO PARTIALLY UNFOLD IN THE WOUND ITSELF AND EVENTUALLY INJECT INTO THE CAPSULAR BAG. THE REMAINDER OF THE CASE WAS NORMAL, EXCEPT THAT THE MAIN WOUND WAS STRETCHED AND DIFFICULT TO RENDER WATERTIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARCH D CARTRIDGE MONARCH III KYB ALCON LABORATORIES 8065977763 32102166

    Patients

    Seq Age Sex Outcome Treatment
    1 *