BEUDAMED
    FDA Adverse Event Summary report: N

    CLEAR CARE

    MDR report key: 8202938 · Received December 27, 2018

    Report

    Report Number
    MW5082660
    Date Received
    December 27, 2018
    Date of Event
    January 1, 2018
    Report Date
    December 27, 2018
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LPN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I WANT TO MAKE A COMPLAINT ABOUT THE ¿CLEAR CARE¿ EYE CONTACT SOLUTION. I BOUGHT THE SOLUTION WHICH CAME IN A BIG BOX WITH TWO 16FL OZ BOTTLES, ONE SMALLER BOTTLE, AND A CASE. ON (B)(6) 2018 AT 6:00PM, I RAN OUT OF THE OPTI FREE SOLUTION WHICH IS WHAT I NORMALLY USE, SO I DECIDED TO MY PUT MY SOFT CONTACT LENSES IN THE NEW SOLUTION I BOUGHT AT (B)(6) WHICH WAS NEXT TO OPTI FREE. ON (B)(6) 2018 AT 8:00AM, I PUT MY CONTACT ON THE LEFT EYE AND MY EYE STARTED BURNING AND STINGING SO BAD THAT I WAS DANCING IN PAIN. I REMOVED THE CONTACT AND WENT TO WORK. THE PAIN WAS SO HARD THAT I HAD TO LEAVE WORK AT 10:30AM TO SEE THE DOCTOR SAID MY EYE WAS BURNED AND GAVE ME ANTI-INFLAMMATORY MEDICATION. BEFORE I MADE MY PURCHASE AT (B)(6), I REMEMBER READING THE TEXT ON THE FRONT OF THE BOX TO MAKE SURE I WAS GETTING A CLEANSER/ DISINFECTING SOLUTION FOR MY CONTACTS AND NOWHERE ON THE FRONT THE BOX DID IT SAY THAT THIS SOLUTION COULD BURN YOUR EYES AND LEAVE YOU WITH PERMANENT CORNEA DAMAGE. AFTER I BURNED MY LEFT EYE, I WENT TO READ THE TEXT ON THE BOTTLE WHERE THE WARNING WAS STATED. I ALSO NOTICED THAT THERE WAS A SMALL WARNING LABEL IN VERY SMALL PRINT ON THE LEFT SIDE OF THE BOX. ALCON LABORATORIES, INC., NEEDS TO PUT A BIG RED LABEL ON THE FRONT OF THE BOX FOR PEOPLE TO UNDERSTAND THAT THIS SOLUTION IS HARMFUL AND CAN CAUSE EYE DAMAGE. IF I WOULD HAVE READ A WARNING IN FRONT OF THE BOX, I WOULDN'T HAVE PURCHASED THIS PRODUCT. MY EYE STILL HURTS, STINGS AND BURNS AND EVEN MY HEAD HURTS. MY NOSE IS CONSTANTLY DRIPPING AND I LOST A DAY OF WORK. PLEASE HAVE ALCON/NOVARTIS LABEL THE FRONT AND BACK OF THE BOX, SO OTHER CUSTOMERS DO NOT GO THROUGH WHAT I WENT THROUGH. THIS IS VERY PAINFUL AND THE USE OF THIS SOLUTION CAN PERMANENTLY DAMAGE YOUR EYE. OUTCOME: VISIT TO AN EMERGENCY ROOM. MORE MEDICINE TO REDUCE OR RELIEVE THE POSSIBLE BAD EFFECTS OF THE ERROR OTHER EXPLANATION; PREDNISOLONE WAS PRESCRIBED 4 TIMES A DAY. REPORTER¿S RECOMMENDATIONS: CLEAR CARE NEEDS TO MAKE THE WARNING PROMINENT IN THE FRONT OF THE BOX, NOT JUST THE BOTTLE. STORES NEED TO SEPARATE CLEAR CARE FROM SOAKING SOLUTIONS. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040344 CLEAR CARE ACCESSORIES, SOFT LENS PRODUCTS LPN ALCON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1