BEUDAMED
    FDA Adverse Event Summary report: N

    CLEAR CARE

    MDR report key: 6456407 · Received March 31, 2017

    Report

    Report Number
    MW5068872
    Date Received
    March 31, 2017
    Report Date
    January 16, 2017
    Manufacturer
    ALCON
    Product Code
    LPN
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED CLEAN CARE EYE WASH THINKING IT WAS REGULAR WASH BECAUSE IT WAS SOLD RIGHT WITH THE REGULAR EYE WASH PRODUCTS. I RINSED MY CONTACT WITH IT, PLACED IT IN MY EYE AND IT FELT LIKE ACID TEARING AT MY EYEBALL. I COULDN'T GET MY EYE TO OPEN TO GET THE CONTACT OUT RIGHT AWAY BECAUSE IT WAS SLAMMED SHUT DUE TO THE PAIN. I FLUSHED MY EYE AND NOW IT'S JUST IRRITATED AND IT HURTS. THE RED WARNING LABEL AT THE TOP I DIDN'T EVEN NOTICE AT FIRST. I THINK IT SHOULD BE PLACED SOMEWHERE OTHER THAN RIGHT WITH THE OTHER WASHES. I ALSO THINK THE LABEL SHOULD HAVE A HUGE WARNING OR CAUTION ACROSS THE LABEL TO DRAW ATTENTION TO IT. MEDICATION ADMINISTERED TO OR USED BY THE PATIENT: YES. PATIENT COUNSELING PROVIDED: UNK. REPORTER'S RECOMMENDATIONS: I THINK IT SHOULD BE PLACED SOMEWHERE OTHER THAN RIGHT WITH THE OTHER WASHES. I ALSO THINK THAT THE LABEL SHOULD HAVE A HUGE WARNING OR CAUTION ACROSS THE LABEL TO DRAW ATTENTION TO IT! DOSAGE FORM: SOLUTION. ADM ROUTE: TOPICAL. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231700 CLEAR CARE CONTACT SOLUTION LPN ALCON

    Patients

    Seq Age Sex Outcome Treatment
    1