BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OAYSIS

    MDR report key: 1222206 · Received November 5, 2008

    Report

    Report Number
    MW5008891
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 5, 1988
    Product Code
    LPL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ACUVUE OAYSIS, BREAKS DOWN AFTER 2 WEEKS, STICKS TO YOUR EYE AND TEARS IT. ENORMOUS AMOUNT OF PAIN. THIS SHOULD BE TAKEN OFF THE MARKET. DOSE OR AMOUNT: ONE LENS PER EYE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OAYSIS DISPOSABLE CONTACT LENSES LPL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR