BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON CLEAR CARE PLUS WITH HYDRA, 3 ML

    MDR report key: 5865469 · Received August 5, 2016

    Report

    Report Number
    MW5063973
    Event Type
    Injury
    Date Received
    August 5, 2016
    Date of Event
    August 3, 2016
    Report Date
    August 5, 2016
    Manufacturer
    ALCON
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED ALCON CLEAR CARE PLUS CONTACT LENS CLEANING AND DISINFECTING SOLUTION WITH HYDRAGLYDE FOR ABOUT TWO WEEKS. I STARTED NOTICING SOME DIFFICULTY WITH VISION CLARITY EARLY THIS WEEK AND ATTRIBUTED IT TO SOME PROBLEM WITH MY SOFT CONTACTS LENSES. IT LOOKED AS THOUGH EVERYTHING WAS CLOUDY OR FOGGY. IT CLEARED UP SOME AFTER A FEW HOURS. YESTERDAY, I HAD EXTREME DIFFICULTY SEEING, REMOVED MY LENSES AND SOAKED THEM IN A RE-WETTING SOLUTION. I NOTICED MY VISION WAS TERRIBLE-COULD NOT SEE THE COMPUTER SCREEN WELL-EVERYTHING LOOKED AS THOUGH I WAS LOOKING THROUGH DARK GRAY GLASS. I THOUGHT THAT I HAD A TIA AND MADE ARRANGEMENTS TO VISIT MY EYE DOCTOR ON MONDAY. MY VISION CLEARED UP AFTER ABOUT SIX HOURS. I USED A DIFFERENT BRAND OF CLEANING SOLUTION LAST NIGHT AND HAVE HAD NO PROBLEMS. I'VE USED REGULAR CLEAR CARE FOR YEARS WITHOUT ANY PROBLEMS AND APPARENTLY PURCHASED THE CLEAR CARE PLUS BY ACCIDENT TWO WEEKS AGO. I HAVE NOTIFIED THE COMPANY ABOUT THE PRODUCT. I PURCHASED LOT NUMBER 259373F WITH EXPIRATION DATE OF 10/2017. AT THE VERY LEAST, SOMETHING NEEDS TO BE ON THE LABEL ABOUT POSSIBLE CLOUDING OF VISION WITH THIS PRODUCT. DATES OF USE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: TO CLEAN SOFT CONTACT LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504028 ALCON CLEAR CARE PLUS WITH HYDRA, 3 ML CONTACT LENSES SOLUTION LPN ALCON H13780-0115

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other