BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMO ARRAY MULTIFOCAL LENS

    MDR report key: 260636 · Received January 25, 2000

    Report

    Report Number
    2648035-2000-00020
    Event Type
    Injury
    Date Received
    January 25, 2000
    Date of Event
    December 20, 1999
    Report Date
    January 24, 2000
    Manufacturer
    ALLERGAN
    Product Code
    MFK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REMOVED AND REPLACED THE LENS DUE TO THE PT'S COMPLAINT OF GLARE. GLARE IS IDENTIFIED AS A PRODUCT RISK IN THE PRODUCT LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO ARRAY MULTIFOCAL LENS SILICONE MULTIFOCAL POSTERIOR CHAMBER LENS MFK ALLERGAN SA40N NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention