BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR CARE EYE SOLUTION

    MDR report key: 2993122 · Received February 26, 2013

    Report

    Report Number
    MW5029196
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 26, 2013
    Manufacturer
    CIBA VISION
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON THE MORNING OF (B)(6) 2013, I WENT TO PUT MY CONTACT LENSES IN AND USED, WHAT I THOUGHT WAS EYE DROPS TO HELP LUBRICATE MY LENSES. I HAD BORROWED MY BOYFRIEND'S CONTACT LENS SOLUTION THAT HE HAD PURCHASED FROM THE STORE THE PREVIOUS DAY. WHEN I WENT TO USE THE CLEAR CARE CONTACT SOLUTION BY CIBA VISION, I IMMEDIATELY FELT AN INTENSE BURNING AND STINGING PAIN IN MY EYE. MY EYE IMMEDIATELY BECAME BLOODSHOT, SWOLLEN, AND RAW. I THEN GOOGLED MY SYMPTOMS TO LEARN THAT THIS HAS HAPPENED TO OTHER CONSUMERS BEFORE, THAT THIS SPECIFIC CONTACT LENS SOLUTION CAN CAUSE SERIOUS CHEMICAL BURNS AND CORNEAL ULCERATIONS IF NOT USED PROPERLY. I HAVE A CHEMICAL BURN IN MY EYE BECAUSE OF THIS. THE LABEL ON THE CONTACT LENS SOLUTION IS NOT CLEARLY MARKED THAT SERIOUS EYE INJURY CAN HAPPEN IF THIS SOLUTION IS NOT USED WITH THE PROPRIETARY CASE. THIS SOLUTION SHOULD NOT BE SOLD AMONGST THE REGULAR CONTACT LENS SALINE SOLUTIONS, AS THIS PRODUCT IS EASILY CONFUSED WITH OTHER NON-HARMFUL PRODUCTS AND CAN EASILY CAUSE INJURY TO THE EYE, ESPECIALLY WHEN THE BOTTLE IS SHAPED AND BRANDED THE EXACT SAME WAY AS REGULAR CONTACT SOLUTION. SOAKED CONTACT LENSES OVERNIGHT; 1X. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81527 CLEAR CARE EYE SOLUTION CONTACT LENS SOLUTION LPN CIBA VISION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other