BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESCRIPTION GLASSES

    MDR report key: 6427256 · Received March 21, 2017

    Report

    Report Number
    MW5068583
    Event Type
    Injury
    Date Received
    March 21, 2017
    Date of Event
    March 21, 2017
    Report Date
    March 21, 2017
    Manufacturer
    ZENNI OPTICAL INC.
    Product Code
    NJH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAVE PURCHASED MULTIPLE SETS OF PRESCRIPTION GLASSES FROM (B)(6) AN ONLINE GLASSES RETAILER. THE GLASSES NEVER SEEM TO HAVE THE RIGHT PRESCRIPTION FOR ME, AS I WOULD HAVE DIFFICULTY SEEING, EYE PAIN, AND FREQUENT HEADACHES. I ASSUMED THAT I WAS ADJUSTING TO THE NEW PRESCRIPTION. AFTER DISCUSSING WITH MY DOCTOR WE DECIDED TO HAVE THE LAST TWO SETS (MULTIPLE PAIRS WERE ORDERED IN 2014 AND 2016) EVALUATED FOR ACTUAL PRESCRIPTION READING. THE PAIRS OF GLASSES ORDERED TOGETHER HAD MATCHING PRESCRIPTION READINGS, HOWEVER BOTH ORDERS SIGNIFICANTLY DIFFERED FROM MY DOCTOR'S PRESCRIPTION FOR MY GLASSES. THE RETAILER WAS CONTACTED, BUT SAID I ONLY HAD A 30 DAY WINDOW FOR RETURNS. WITH GLASSES, I SHOULD HAVE RETURNED THEM WITHIN THE RETAILER POLICY WINDOW, BUT I DON'T WANT OTHER CONSUMERS TO SUFFER THE CONSEQUENCES I HAVE DEALT WITH THIS PAST TWO YEARS. I'M NOT INTERESTED IN GETTING MONEY BACK. I'M UPSET THAT AS A PATIENT THERE IS NO EASY WAY TO SHOW THE DOCTORS PRESCRIBED ORDERS WERE ACCURATELY FILLED WITH MY PRESCRIPTION GLASSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202985 PRESCRIPTION GLASSES LENS, SPECTACLE, NON-CUSTOMER (PRESCRIPTION) NJH ZENNI OPTICAL INC.
    202986 PRESCRIPTION GLASSES LENS, SPECTACLE, NON-CUSTOMER (PRESCRIPTION) NJH ZENNI OPTICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR