BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUXOTTICA

    MDR report key: 908352 · Received August 30, 2007

    Report

    Report Number
    MW5003635
    Event Type
    Injury
    Date Received
    August 30, 2007
    Date of Event
    January 1, 1982
    Report Date
    August 30, 2007
    Manufacturer
    LUXOTTICA GROUP SPA
    Product Code
    HQZ
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHEN I WAS WEARING LUXOTTICA EYEGLASSES IN 1982, I WAS INVOLVED IN A CAR ACCIDENT. SOMETHING IN THE RIGHT LANE IN WHICH I WAS DRIVING CAUSED ME TO AVOID A COLLISION BY APPLYING THE BRAKES SUDDENLY AND SWERVING INTO THE LEFT LANE OF THE SAME HIGHWAY AT THE TIME OF THE ACCIDENT. I MAY HAVE BEEN INJURED FROM THE ACCIDENT. IN 1981, WHILE I WAS WEARING THE SAME LUXOTTICA EYEGLASSES, DR PRESCRIBED FOR ME ELAVIL BRAND PHARMACEUTICAL DRUG, GENERIC NAME IMIPRAMINE. AFTER I TOOK THE ELAVIL, I FELL ASLEEP WHILE I WAS SITTING AT A DINING ROOM TABLE WAITING FOR A MEAL. NOW THAT I DO NOT WEAR ANY EYE CORRECTIVE LENSES, EYEGLASSES, SPECTACLES, CONTACTS, OR ANY CONTACT LENSES AS OF 2001, I DO NOT TAKE ANY PSYCHIATRIC PHARMACEUTICAL DRUGS ANYMORE, NOR DO I DRIVE ANY VEHICLES ANYMORE. DATES OF USE: #1. 1981-2001, #2 1981-2006. DIAGNOSIS OR REASON FOR USE: #1 NEARSIGHTEDNESS, MILD AMBLYOPIA, #2. EMOTIONAL SENSITIVITIES, EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED" #1. YES, #2 YES. EVENT REAPPEARED AFTER REINTRODUCTION? #1. YES, #2. YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUXOTTICA EYEGLASSES HQZ LUXOTTICA GROUP SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| L