BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMO ARRAY MULTIFOCAL LENS

    MDR report key: 259605 · Received January 21, 2000

    Report

    Report Number
    2648035-2000-00019
    Event Type
    Injury
    Date Received
    January 21, 2000
    Date of Event
    November 16, 1999
    Report Date
    January 21, 2000
    Manufacturer
    ALLERGAN
    Product Code
    MFK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REMOVED AND REPLACED THE LENS DUE TO THE PT'S COMPLAINT OF HALOS. HALOS ARE 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 68 YR Required Intervention