BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTACLES

    MDR report key: 10075699 · Received May 19, 2020

    Report

    Report Number
    MW5094612
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Date of Event
    January 1, 2020
    Report Date
    May 15, 2020
    Manufacturer
    UNK
    Product Code
    HQG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SPECTACLE (21 CFR SECTION 886.5844) SELLER BUNDLED "COATING" WITH SALE OF PRESCRIPTION EYEGLASSES. THE COATING HAS WORN UNEVENLY, AND CANNOT BE CLEANED. MERCHANT SAYS (AND WEB ARTICLES STATE) THAT THE "COATING" CANNOT BE REMOVED, SO I AM STUCK WITH GLASSES OF THE RIGHT PRESCRIPTION, BUT BLOTCHY "COATING". WHERE MAY I SEE FDA'S APPROVAL OR CLEARANCE OF SUCH COATINGS? HOW LONG DID THE MANUFACTURER OF EYEGLASS COATING SUBSTANCES TELL FDA THEY WOULD LAST? DOES FDA CLAIM THAT BLOTCHY COATINGS ARE, OR ARE NOT SIGNIFICANT TO THE USER? WHERE MAY I REVIEW THE NUMBER OF SIMILAR COMPLAINTS TO FDA ABOUT EYEGLASS COATINGS? I HAVE NO TESTS. I DO NOT BELIEVE THAT I HAVE BEEN INJURED BY THIS DEVICE, BUT I BELIEVE THE CHARACTERISTIC OF UNEVEN WEAR OF SUCH COATINGS IS A QUALITY ISSUE THAT SHOULD BE THE SUBJECT OF REQUIRED FDA-DIRECTED WARNING LABELS ON ALL SUCH PRODUCTS, AND THAT FDA SHOULD PUBLISH AN ALERT TO EYEGLASS CUSTOMERS ABOUT THE FACT AND LIKELIHOOD OF SUCH DEGRADATION FOR COATED EYEGLASSES, BOUGHT AT (B)(6); NEEDS GLASSES. NEEDS EFFECTIVE GOVERNMENT REGULATION AND ENFORCEMENT FOR DEVICES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534630 SPECTACLES LENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) HQG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR