BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARILUX PHYSIO

    MDR report key: 2943722 · Received February 5, 2013

    Report

    Report Number
    MW5028818
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    July 18, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ESSILOR USA, INC
    Product Code
    HQG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BOTH PRESCRIPTION LENSES CATASTROPHICALLY FAILED AND I WAS UNABLE TO SEE WELL ENOUGH TO DRIVE A VEHICLE. I LEFT MY REGULAR PRESCRIPTION EYE WEAR IN MY VEHICLE AND USED MY PRESCRIPTION SUNGLASSES DURING THE DAYTIME. AT NIGHT, WHEN I RETURNED TO MY VEHICLE, I SWITCHED TO MY REGULAR PRESCRIPTION EYE WEAR BUT COULD NOT SEE PROPERLY TO DRIVE. I WAS ABOUT 40 MILES FROM MY MOTEL AND HAD TO USE SUNGLASSES TO RETURN TO THE MOTEL. I DO NOT BELIEVE THAT ESSILOR USA, INC. ADEQUATELY ALERTS USERS OF THEIR PRESCRIPTION LENSES OF THE LOW TEMPS AT WHICH THEIR LENSES CAN FAIL CATASTROPHICALLY. ESSILOR USA, INC. HAS FAILED TO PROVIDE ME WITH THE HEAT DISTORTION TEMP THAT CAN CAUSE CATASTROPHIC FAILURE AS REQUESTED. THEY ONLY STATE THAT THEIR LENSES SHOULD NOT BE KEPT IN A VEHICLE. BASED ON MY EXPERIENCE, THE HEAT REQUIRED FOR CATASTROPHIC FAILURE IS UNREASONABLE LOW AND THE PRODUCT SHOULD NOT BE ALLOWED TO BE MARKETED. DATES OF USE: (B)(6) 2010 - (B)(6) 2012. DIAGNOSIS OR REASON FOR USE: LENSES TO CORRECT EYE SIGHT. I HAVE WORN PRESCRIPTION LENSES FOR APPROXIMATELY 60 YRS AND NEVER HAD HEAT DAMAGE TO LENSES WHEN I KEPT EYE WEAR IN AS VEHICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48272 VARILUX PHYSIO PROGRESSIVE PRESCRIPTION LENSES HQG ESSILOR USA, INC AR CRIZAL ADVANCED

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other