BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTI FREE EXPRESS NO RUB DISINFECTION FORMULA

    MDR report key: 411825 · Received July 12, 2002

    Report

    Report Number
    MW4003321
    Event Type
    Other
    Date Received
    July 12, 2002
    Date of Event
    January 1, 2002
    Report Date
    July 12, 2002
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER USED PRODUCT FROM NEW BOTTLE FOR APPROX 3 WEEKS AND THEN WOKE UP AND COULDN'T SEE OUT OF LEFT EYE. THEY SAW THEIR OPTOMETRIST WHO TOLD THEM THAT THEY HAD PERFORATIONS UNDER EACH CORNEA. THEY WERE REFERRED TO A NEUROOPHTHALMOLOGIST WHO RULED OUT EYE DISEASES. CONSUMER SAID THEY HAVE STOPPED USING THE CONTACTS (SOFT) AND THE SOLUTION APPROX 2 WEEKS AGO AND EYES ARE BEGINNING TO IMPROVE. THEY HAVE WORN SOFT CONTACTS FOR YEARS WITH NO HISTORY OF PROBLEMS. THEY REPORTED THAT THEY NEXT USED THE OPTI FREE NO RUB DISINFECTION FORMULA MANY TIMES IN THE PAST WITH NO ADVERSE REACTION. PER PHONE CONVERSATION ON 07/2002 WITH STORE'S ASST MGR NO OTHER COMPLAINTS HAVE BEEN RECEIVED ON THIS PRODUCT. PER PHONE CONVERSATION ON 07/2002 WITH CONSUMER AFFAIRS FOR ALCON NO OTHER COMPLAINTS AT ALL HAVE BEEN RECEIVED ON THE ABOVE-MENTIONED LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI FREE EXPRESS NO RUB DISINFECTION FORMULA DISINFECTION CLEANER LPN ALCON LABORATORIES, INC. NA 3382F

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other