BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 3820474 · Received May 15, 2014

    Report

    Report Number
    MW5036146
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 14, 2014
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I'VE WORN ACUVUE DAY CONTACT LENSES FOR 20 YEARS. ON MY LAST EYE CHECK UP, MY DOCTOR CHANGED MY CONTACT TO ACUVUE OASYS. SINCE THE CHANGE, I'VE EXPERIENCED: SWELLING OF THE EYE/PUPIL; ITCH ON THE EYE, EYELID AND EYELASH AREA; IRRITATION ON THE OUTER EYELID; BLURRED VISION, KEEPS GETTING WORSE; KERATITIS, DOCTOR TREATED FOR A PERIOD OF 4 WEEKS. I KEPT HAVING ISSUES WITH MY EYE, BUT I THOUGHT IT WAS "AGE" RELATED OR ALLERGIES UNTIL I READ THAT THIS PARTICULAR BRAND CAUSES EYE ALLERGIES AND SIDE EFFECTS SUCH AS THE ONES I DESCRIBED. I CONTACTED J & J AND THEY ASKED ME TO VISIT AN EYE DOCTOR TO MAKE SURE THERE ARE NO SERIOUS ISSUES AND TO CHANGE TO ANOTHER CONTACT LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289746 ACUVUE OASYS CONTACT LENS LPL JOHNSON & JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Disability