BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMO ARRAY MUTIFOCAL LENS

    MDR report key: 465170 · Received June 9, 2003

    Report

    Report Number
    2648035-2003-00110
    Event Type
    Injury
    Date Received
    June 9, 2003
    Date of Event
    April 1, 2003
    Report Date
    May 9, 2003
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    MFK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REMOVED AND REPLACED THE DEVICE DUE TO OBSERVATION OF A WHITE OPTIC ON THE IMPLANTED LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO ARRAY MUTIFOCAL LENS SILICONE MULTIFOCAL POSTERIOR CHAMBER LENS MFK ADVANCED MEDICAL OPTICS SA40N UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention CYTOSTATIC DRUGS.