BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRIZAL

    MDR report key: 309553 · Received December 13, 2000

    Report

    Report Number
    MW1020652
    Event Type
    Malfunction
    Date Received
    December 13, 2000
    Report Date
    November 26, 2000
    Manufacturer
    ESSILOR INTL ESSILOR OF AMERICA, INC.
    Product Code
    HQG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CREATED UNSAFE DRIVING CONDITIONS DUE TO BLURRING OF VISION. AFTER ONE MONTH OF USE LENSES DEVELOPED TINY CIRCULAR SCRATCH MARKS. PT WAS VERY CAREFUL TO USE ONLY THE SUPPLIED CLEANING CLOTH TO CLEAN LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRIZAL ANTI-REFLECTIVE LENSE COATING HQG ESSILOR INTL ESSILOR OF AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other