BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLEAR CARE

    MDR report key: 6102275 · Received November 11, 2016

    Report

    Report Number
    MW5066028
    Event Type
    Other
    Date Received
    November 11, 2016
    Date of Event
    January 1, 2016
    Report Date
    August 17, 2016
    Manufacturer
    ALCON
    Product Code
    LPN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WOMAN JUST CALLED TO REPORT SHE PUT CLEAR CARE DIRECTLY IN HER EYE WITHOUT USING THE NEUTRALIZING CASE. THIS OCCURRED 2 HOURS AGO AND SHE IS STILL IN SEVERE PAIN. SHE STATED SHE HAD ONCE USED THIS PRODUCT SIX MONTHS AGO. SHE USUALLY JUST USES SALINE BUT SINCE HER CONTACTS WERE MORE DIRTY THAN USUAL SHE DECIDED TO USE THIS PRODUCT. SHE KNEW IT HAD TO BE "NEUTRALIZED" BUT DIDN'T REALIZE IT HAD TO BE IN A SPECIAL CASE. SHE LET HER CONTACTS SIT FOR SIX HOURS IN A REGULAR LENS CASE. SHE PUT ONE IN HER EYE AND IMMEDIATELY FELT THE WORST PAIN IN HER LIFE. SHE SAID THE PAIN WAS SO SEVERE IT ACTUALLY CAUSED HER TO URINATE HERSELF. HER WHOLE DAY HAS BEEN INTERRUPTED BECAUSE OF THIS. SHE IS ALSO VERY UPSET BECAUSE HER TEENAGE DAUGHTER IS A BRAND NEW CONTACT LENS WEARER AND SHE COULD HAVE EASILY USED THIS PRODUCT AS REGULAR LENS SOLUTION. MEDICATION ADMINISTERED TO OR USED BY THE PT: NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747749 CLEAR CARE CONTACT LENSE SOLUTION LPN ALCON

    Patients

    Seq Age Sex Outcome Treatment
    1