BEUDAMED
    FDA Adverse Event Other Summary report: N

    MANY

    MDR report key: 4189192 · Received October 14, 2014

    Report

    Report Number
    MW5038644
    Event Type
    Other
    Date Received
    October 14, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MANY
    Product Code
    HQY
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THERE ARE NO WARNINGS ON CHEAP NONPRESCRIPTION SUNGLASSES THAT SAY THEY DO NOT STOP UV RADIATION WHICH IS DAMAGING TO THEY EYES. I THOUGHT THAT SINCE THE FDA HAD STANDARDS FOR SUNGLASSES THAT ANY SUNGLASSES I WOULD BUY WOULD PROVIDE UV PROTECTION. INSTEAD OF PROTECTING THE EYES, SOME BRANDS OF SUNGLASSES DAMAGE THE EYES BECAUSE THEY CAUSE PUPILS TO OPEN AND ADMIT MORE UV. GLASSES THAT DO NOT PROTECT THE EYES AGAINST UV SHOULD HAVE A STATEMENT ON THEIR LABEL SAYING THAT. DIAGNOSIS OR REASON FOR USE: PROTECTION OF EYES FROM EFFECTS OF UV FROM SUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648749 MANY SUNGLASSES HQY MANY

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR