BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMO ARRAY MULTIFOCAL LENS

    MDR report key: 466074 · Received June 9, 2003

    Report

    Report Number
    2648035-2003-00111
    Event Type
    Malfunction
    Date Received
    June 9, 2003
    Date of Event
    April 1, 2003
    Report Date
    May 9, 2003
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    MFK
    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 ON AN IMPLANTED LENS. PT'S VISUAL ACUITY IS EXCELLENT AND PHYSICIAN HAS NO PLANS TO EXPLANT.

    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 SA40N UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN