BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON

    MDR report key: 764921 · Received September 26, 2006

    Report

    Report Number
    MW1040505
    Event Type
    Malfunction
    Date Received
    September 26, 2006
    Date of Event
    September 18, 2006
    Report Date
    September 20, 2006
    Manufacturer
    ALCON
    Product Code
    KYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AS IOL WAS BEING INJECTED THROUGH THE DELIVERY SYSTEM, THE CARTRIDGE BEGAN CRACKING AT DISTAL END. THE INCISION LENGTH WAS 2.75 M.M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON MONARCH II - "C" CARTRIDGE DELIVERY SYSTEM KYB ALCON 8065977759 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR