BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMO ARRAY MULTIFOCAL LENS

    MDR report key: 550494 · Received April 13, 2004

    Report

    Report Number
    2648035-2004-00184
    Event Type
    Malfunction
    Date Received
    April 13, 2004
    Date of Event
    February 19, 2004
    Report Date
    March 25, 2004
    Manufacturer
    ADVANCED MEDICAL OPTICS,
    Product Code
    MFK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN OBSERVED A CLOUDY OPTIC AT ONE DAY POST OPERATIVE. LENS CLEARED WITHIN A FEW DAYS AND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO ARRAY MULTIFOCAL LENS SILICONE MULTIFOCAL POSTERIOR CHAMBER LENS MFK ADVANCED MEDICAL OPTICS, SA40NB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR