BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR CARE 3 PERCENT HYDROGEN PEROXIDE

    MDR report key: 3932755 · Received July 9, 2014

    Report

    Report Number
    MW5037233
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 8, 2014
    Manufacturer
    CIBA VISION
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS IS ABOUT "CLEAR CARE" CONTACT LENS CLEANING AND STORAGE PRODUCT. IT IS A NEW PRODUCT THAT USES 3 PERCENT HYDROGEN PEROXIDE. IT IS DESTROYING MY SOFT CONTACT LENSES. IN THREE WEEKS OF USE, MY CONTACT LENSES ARE BEING WITHIN A FEW DAYS OF USE. I AM NOT DOING ANY NORMAL RUBBING FOR CLEANING THE LENSES AS WITH MY OTHER STORAGE SOLUTIONS. I SIMPLY STORE THE LENSES IN THE PROVIDED CASE AND PUT THEM INTO THE SOLUTION FOR OVERNIGHT STORAGE, AS DIRECTED. THERE SHOULD MINIMALLY BE A WARNING THAT THIS PRODUCT IS HARMFUL TO CERTAIN TYPES OF SOFT CONTACT LENSES AND MAY CAUSE THE RAPID DETERIORATION OF THEIR STRUCTURAL INTEGRITY. I AM ABANDONING THIS PRODUCT AND RETURNING TO MORE TRADITIONAL LENS SOLUTIONS. DOSE OR AMOUNT: FILL PROVIDED VESSEL. FREQUENCY: ONCE DAILY. DATES OF USE: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399045 CLEAR CARE 3 PERCENT HYDROGEN PEROXIDE LENS CLEANING AND DISINFECTIOR, 1202 LPN CIBA VISION G1418H1

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other