BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMO ARRAY MULTIFOCAL LENS

    MDR report key: 591353 · Received June 3, 2004

    Report

    Report Number
    2648035-2004-00190
    Event Type
    Malfunction
    Date Received
    June 3, 2004
    Date of Event
    May 3, 2004
    Report Date
    May 18, 2004
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN OBSERVED A CLOUDY OPTIC POST OPERATIVE IMPLANT OF THE DEVICE. NO EFFECT ON PATIENT'S VISUAL ACUITY AND LENS REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN