BEUDAMED
    FDA Adverse Event Summary report: N

    1.57 PHOTOCHROMIC SINGLE VISION-AMBER ZENNI OPTICAL LENS

    MDR report key: 6307403 · Received February 6, 2017

    Report

    Report Number
    MW5067692
    Date Received
    February 6, 2017
    Date of Event
    December 27, 2015
    Report Date
    January 21, 2017
    Manufacturer
    ZENNI OPTICAL
    Product Code
    HQY
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I PURCHASED UV BLOCKING PHOTOCHROMIC GLASSES FROM ZENNI OPTICAL. I TESTED THEM AFTER USING THEM FOR A YEAR, AND THEY DON'T BLOCK UV LIGHT. I AM CONCERNED ABOUT THE DAMAGE DONE TO MY EYES. RETAILED: (B)(6). PURCHASE DATE: (B)(6) 2015. THE PRODUCT WAS DAMAGED BEFORE THE INCIDENT: NO. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT: NO. ZENNI OPTICAL FRAMES AND LENSES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88514 1.57 PHOTOCHROMIC SINGLE VISION-AMBER ZENNI OPTICAL LENS ZENNI OPTICAL LENS HQY ZENNI OPTICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR