BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESCRIPTION SUNGLASSES

    MDR report key: 9871760 · Received March 23, 2020

    Report

    Report Number
    MW5093902
    Event Type
    Injury
    Date Received
    March 23, 2020
    Date of Event
    March 18, 2020
    Report Date
    March 19, 2020
    Manufacturer
    UNK
    Product Code
    HQG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED LENSES ON AN UPDATED OPTICAL PRESCRIPTION FOR BOTH REGULAR GLASSES AND SUNGLASSES FROM MY LOCAL OPTOMETRIST UNDER MY (B)(6) INSURANCE PLAN THROUGH MY EMPLOYER. IT TOOK 3-WEEKS FOR THE LENSES TO BE AVAILABLE TO ME. WHEN I PICKED THEM UP, THEY REFUSED TO FIT MY GLASSES OR EVEN PERMIT ME TO ENTER THE OFFICE. I WORE THE SUNGLASSES FOR A FEW DAYS AND STARTED TO EXPERIENCE EYE STRAIN AND DIZZYNESS AS A SIDE EFFECT OF THE POLARIZATION . NOW THEY ARE REFUSING TO TOUCH THE GLASSES OR PROCESS AN ORDER FOR REPLACEMENT LENSES WITHOUT POLARIZATION. THEY ARE CITING CORONAVIRUS AS CAUSE FOR BEING UNABLE TO COME INTO CONTACT WITH PTS OR WITH ANYTHING THAT PTS HAVE TOUCHED. THEY ARE REFUSING EVEN TO ATTEMPT TO SANITIZE ANYTHING TO WEAR GLOVES, OR EXERCISE OTHER COMMON SENSE SAFE-HANDLING PROCEDURES IN SERVICE OF THEIR EYE CARE PTS. MEANWHILE, I CAN'T WEAR MY NEW PRESCRIPTION SUNGLASSES WITHOUT SERIOUS RISK OF DISORIENTATION - ESPECIALLY WHILE DRIVING. APPT DATELINE (B)(6) 2020 AT 10:40 AM, (B)(6). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327608 PRESCRIPTION SUNGLASSES LENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) HQG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention