BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR CARE CONTACT SOLUTION

    MDR report key: 2896962 · Received January 3, 2013

    Report

    Report Number
    MW5028423
    Event Type
    Injury
    Date Received
    January 3, 2013
    Manufacturer
    CIBA VISION
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

    (B)(4) - SERIOUS INJURIES. (B)(4). I JUST WANTED TO CALL TO YOUR ATTENTION A PROBLEM WITH A CONTACT LENS SOLUTION THAT I UNDERSTAND YOU MAY ALREADY HAVE HEARD ABOUT IN THE PAST BUT MAY NOT KNOW THAT INJURIES CONTINUE TO OCCUR. A FRIEND IN MY OFFICE JUST INFORMED EVERYONE HERE TODAY THAT HER DAUGHTER, A NURSE, WAS RECENTLY INJURED BY USE OF CLEAR CARE CONTACT SOLUTION WHICH IS MANUFACTURED BY CIBA VISION. HER DAUGHTER IS NOW OFF WORK FOR THREE DAYS FOLLOWING AN INJURY TO HER EYES FROM USE OF THIS CONTACT SOLUTION. MY FRIEND TOLD ME THAT ANOTHER FRIEND OF HER DAUGHTER WAS ALSO RECENTLY INJURED. I IMMEDIATELY CONTACTED MY DAUGHTER IN (B)(6), A PT OF YOURS, TO INFORM HER ABOUT THIS CONTACT SOLUTION AND WAS TOLD BY MY DAUGHTER THAT SHE TOO SUFFERED A SIMILAR INJURY ABOUT SIX-MONTHS TO A YEAR AGO FROM THIS CONTACT SOLUTION. NONE OF US HAD EVER HEARD OF THE PREVIOUS WARNING ABOUT THIS PRODUCT (B)(4). THE NUMBER OF INJURIES IS ALARMING TO ME AND (B)(4) SAYS INJURIES CONTINUE TODAY, SOME SEVERE. DATES OF USE: (B)(6) 2012. DIAGNOSIS OR REASON FOR USE: SEVERE EYE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2898 CLEAR CARE CONTACT SOLUTION NONE LPN CIBA VISION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other| R