BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMO COMPLETE MOISTUREPLUS

    MDR report key: 868246 · Received June 18, 2007

    Report

    Report Number
    MW5002701
    Event Type
    Injury
    Date Received
    June 18, 2007
    Date of Event
    June 16, 2007
    Report Date
    June 18, 2007
    Manufacturer
    ADVANCED MEDICAL OPTIONS, INC.
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN USING THE AMO COMPLETE MOISTUREPLUS SOFT CONTACT LENS SOLUTION SINCE 2007. I WAS TOLD BY A FRIEND ON SATURDAY, THAT THE PRODUCT HAD BEEN RECALLED. I PREVIOUSLY THOUGHT THE BURNING SENSATION IN MY EYES WAS DUE TO NOT CLEANING MY LENSES OFTEN ENOUGH. DATES OF USE: FIVE MONTHS IN 2007. DIAGNOSIS OR REASON FOR USE: SOLUTION FOR CONTACT LENSES. EVENT ABATED AFTER USE: NO. DOSE OR AMOUNT: SEVERAL DROPS. FREQUENCY: 2-4 TIMES A WEEK. ROUTE: INTRAOCULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO COMPLETE MOISTUREPLUS MOISTUREPLUS SOLUTION LPN ADVANCED MEDICAL OPTIONS, INC. AB03996

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR