BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMO CARTRIDGE

    MDR report key: 1212383 · Received October 8, 2008

    Report

    Report Number
    1212383
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 8, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    POSSIBLE DEFECT NOTED IN CARTRIDGE OF LENS AFTER LENS WAS INSERTED. SCRATCH NOTED ON THE OUTSIDE ASPECT OF LENS. NO FOREIGN MATERIAL NOTED IN EYE AFTER EXTENSIVE EXAMINATION UNDER MICROSCOPE. NO PATIENT HARM IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO CARTRIDGE CARTRIDGE, OCULAR HQC ADVANCED MEDICAL OPTICS, INC. * 8EG056

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR