BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYCARBONATE EYEGLASS LENSES POLY FTHRWTS CLASSIC PREM AR SINGLE VISION PREMIUM

    MDR report key: 7718218 · Received July 24, 2018

    Report

    Report Number
    MW5078609
    Event Type
    Malfunction
    Date Received
    July 24, 2018
    Date of Event
    July 23, 2018
    Report Date
    July 23, 2018
    Manufacturer
    LUXOTTICA GROUP SPA
    Product Code
    HQG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PURCHASED POLYCARBONATE EYEGLASS LENSES FROM (B)(6). THE LENS CRACKED AFTER SIX MONTHS. THIS IS THE SECOND PAIR THIS HAS HAPPENED TO (WHICH NECESSITATED THE PURCHASE OF THESE LENSES.). (B)(6) DOES NOT STAND BEHIND THEIR PRODUCT UNLESS YOU PAY FOR AN ADDITIONAL INSURANCE PRODUCT. PURCHASING POLYCARBONATE IS DONE FOR SAFETY. THEIR PRODUCT IS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558514 POLYCARBONATE EYEGLASS LENSES POLY FTHRWTS CLASSIC PREM AR SINGLE VISION PREMIUM LENS, SPECTACLE, NON-CUSTOM HQG LUXOTTICA GROUP SPA VO 3940
    558515 POLYCARBONATE EYEGLASS LENSES POLY FTHRWTS CLASSIC PREM AR SINGLE VISION PREMIUM LENS, SPECTACLE, NON-CUSTOM HQG LUXOTTICA GROUP SPA VO 3940

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR