BEUDAMED
    FDA Adverse Event Other Summary report: N

    OAKLEY BRAND SUNGLASSES

    MDR report key: 4802297 · Received May 22, 2015

    Report

    Report Number
    MW5042848
    Event Type
    Other
    Date Received
    May 22, 2015
    Date of Event
    May 8, 2015
    Report Date
    May 8, 2015
    Manufacturer
    OAKLEY
    Product Code
    HQY
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SINCE NEW, ANYTIME I WEAR THESE SUNGLASSES, THEY FOG UP QUICKLY AND WITHOUT NOTICE. AT FIRST, I WAS NOT TERRIBLY CONCERNED. HOWEVER, TODAY WHILE DRIVING MY CAR AT APP 55 MPH, THE SUNGLASSES SUDDENLY FOGGED AND COMPLETELY OBSCURED MY FIELD OF VISION. THIS EASILY COULD HAVE CAUSED AN ACCIDENT. I WAS TRAVELING IN THE VEHICLE FOR NEARLY AN HOUR WHEN THIS HAPPENED WITH THE WINDOWS UP AND THE AIR CONDITIONING ON THE LOW SETTING. THERE WERE NO SUDDEN TEMPERATURE OR HUMIDITY CHANGES. I SENT AN EMAIL TO THE MANUFACTURER VIA THEIR WEBSITE. PURCHASE DATE: (B)(6) 2015. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337396 OAKLEY BRAND SUNGLASSES SUNGLASSES HQY OAKLEY VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR