BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EYEGLASSES

    MDR report key: 7241006 · Received February 2, 2018

    Report

    Report Number
    MW5075064
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    February 1, 2018
    Report Date
    February 1, 2018
    Manufacturer
    UNK
    Product Code
    HQG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I ORDERED TWO SETS OF GLASSES FROM (B)(4). THERE APPARENTLY WAS NO QUALITY CONTROL OF THE GLASSES. THE IMAGE THROUGH BOTH WAS BADLY DISTORTED. I AM CONCERNED ABOUT (B)(4) DISTRIBUTING GLASSES WITH NO QUALITY CONTROL, WHICH COULD HURT PEOPLE'S SIGHT AND MAYBE CAUSE FALLS. I HAVE PHOTOS TAKEN THROUGH THE GLASSES AND WITHOUT THE GLASSES THAT PROVE THE DISTORTION. ZENNI OPTICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82461 EYEGLASSES LENS, PRESCRIPTION EYE GLASSES HQG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR