BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLEAR CARE

    MDR report key: 6154481 · Received December 7, 2016

    Report

    Report Number
    MW5066582
    Event Type
    Other
    Date Received
    December 7, 2016
    Date of Event
    January 1, 2016
    Report Date
    September 11, 2016
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LPN
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CLEAR CARE CONTACT LENS SOLUTION WAS USED TO RINSE CONTACTS. FINAL OUTCOME: TEMPORARY HARM/INJURY. A DAY LATER MY EYE IS STILL RED, SWOLLEN, AND SORE. MORE MEDICINE TO REDUCE OR RELIEVE THE POSSIBLE BAD EFFECTS OF THE ERROR. HOPING IT HEALS ON ITS OWN. WHEN I FELT THE FIRE OF A THOUSAND SUNS CONCENTRATED INTO A MILLION NEEDLE PRICKS IN MY EYEBALL. THE BOTTLE IS THE EXACT SAME SIZE AND SHAPE AS OTHER PRODUCTS, SUCH AS SALINE. THE FLIP TOP IS THE SAME DESIGN. YES, IT'S RED, BUT THE AMOUNT OF TEXT ON THE WARNING BAND MAKES IT BLEND IN. JUST SAY WARNING! I HAD JUST TAKEN MY CONTACTS OUT OF THE CASE SO I KNOW THE DIFFERENCE AND STILL MADE THIS ERROR. GOOGLING BROUGHT A SLEW OF SIMILAR COMPLAINTS. IT'S SHOCKING NOTHING HAS BEEN DONE TO FIX THIS. RELEVANT MATERIAL NOT PROVIDED. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800868 CLEAR CARE CONTACT SOLUTION LPN ALCON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1