BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR CARE NO RUB

    MDR report key: 2113393 · Received May 26, 2011

    Report

    Report Number
    MW5020832
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    CIBA VISION
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED CLEAR CARE FROM CIBA VISION A "NO RUB" CONTACT LENS CLEANING AND DISINFECTING SOLUTION. THIS IS WHAT I THOUGHT WAS A NORMAL CONTACT LENS CLEANING SOLUTION LIKE ALL OTHERS THAT WERE AROUND IT DURING THE TIME OF PURCHASE. I OPENED THE PACKAGE ON (B)(6) 2011 AND PLACED MY LENSES IN MY REGULAR CONTAINER AND POURED THE CLEAR CARE OVER THEM. I WOKE UP ON THE MORNING OF (B)(6) 2011 AND PLACED A CONTACT LENS INTO MY RIGHT EYE. I IMMEDIATELY FELT MY EYE BURNING AND MY EYE CLENCHED SHUT. I ATTEMPTED TO OPEN MY EYE WITH MY OTHER HAND AND AFTER A FEW TRIES TOOK OUT THE CONTACT LENS AND PROCEEDED TO RINSE OUT MY EYE. I FIND OUT AFTER THE FACT THAT CLEAR CARE HAS A SOLUTION OF HYDROGEN PEROXIDE THAT WILL BURN YOUR EYE UNLESS YOUR CONTACTS ARE DISINFECTED SOLELY IN THE CONTACT CASE THEY PROVIDE. IT SEEMS THAT THE CASE THEY PROVIDE HAS METAL IN IT THAT WILL DEACTIVATED THE PEROXIDE AFTER ABOUT 6 HRS THEREBY ALLOWING YOU TO PLACE IT IN YOUR EYES. THE FUNNY THING IS THAT THE BOX ONLY HAS A WARNING ON THE BACK THAT STATES "DO NOT USE FLAT LENS CASE. CLEAR CARE ONLY WORKS WITH THE SPECIAL LENS PROVIDED." IT DOES NOT STATE THAT USING THIS SOLUTION W/O THE CASE WILL BURN YOUR EYES. OBVIOUSLY IF IT HAD A WARNING SUCH AS THIS, THEIR PRODUCT WOULD NOT SELL. THE PRODUCT LOOKS LIKE ALL OTHER SOLUTIONS, IS SOLD NEXT TO ALL OTHER SOLUTIONS, IT IS LABELED LIKE ALL OTHER SOLUTIONS AND HAS NO WARNING (EXCEPT PRINTED ON THE INSIDE OF THE BOX) THAT ITS PRODUCT COULD CAUSE CORNEA BURNS AND DAMAGE. THIS PRODUCT CAUSED ME TO SUFFER EXTREME PAIN FOR THE DAY AND REQUIRED ME TO SEE MY OPTOMETRIST TO GET ANTI-INFLAMMATION DROPS. I SHUDDER TO THINK OF THE DAMAGE THIS COULD CAUSE SOMEONE IF THEY WERE IN A POSITION IN WHICH THEY COULD NOT RINSE THEIR EYES OUT. THIS PRODUCT SHOULD NOT BE SOLD OR SHOULD BE CLEARLY LABELED THAT IMPROPER USE COULD CAUSE BURNING AND DAMAGE TO THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR CARE NO RUB CONTACT LENS CLEANING AND DISINFECTING SOLUTION LPN CIBA VISION 87177

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other