BEUDAMED
    FDA Adverse Event Injury Summary report: N

    "VARILUX" BRAND LENS

    MDR report key: 326999 · Received April 11, 2001

    Report

    Report Number
    MW1021620
    Event Type
    Injury
    Date Received
    April 11, 2001
    Date of Event
    January 1, 2001
    Manufacturer
    DR. DAVID KYLE
    Product Code
    HQG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE SIDES OF THESE BRAND LENSES ARE PRISMS, NOT LENSES. ONLY THE CENTER STRIP IS GROUND LENSES. THEREFORE EVERYTHING TO THE (SLIGHTEST) SIDE APPEARS TO BE AIRBORN AND FURRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16503 "VARILUX" BRAND LENS GLASSES-PRESCRIPTION HQG DR. DAVID KYLE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R| S BRANDS.| ALL VARIABLE FOCUS GLASSES LENSES - SEVERAL