BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAN CARE CLEANING SOLUTION

    MDR report key: 2820909 · Received October 31, 2012

    Report

    Report Number
    MW5027435
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 31, 2012
    Manufacturer
    CIBA VISION
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE EXPIRATION DATE 08/2013 AND LOT NUMBER 12211 ON THE ACTUAL CONTAINER OF CLEAR CARE CLEANING AND DISINFECTING SOLUTION IS DIFFERENT FROM THE EXPIRATION DATE 05/2013 AND LOT NUMBER 16118 ON THE OUTSIDE CARTON. WHEN I CALLED THE CIBA VISION COMPANY, AN INDIVIDUAL ADVISED ME THAT THIS WAS THE CASE ON ALL SUCH PRODUCTS. HOWEVER, WHEN I REVIEWED MY OTHER CLEAR CARE PACKAGES, THIS WAS NOT THE CASE. ALSO, AS A PHARMACIST AND FORMER STATE HEALTH INVESTIGATOR, I KNOW THAT THIS IS AN INCORRECT STATEMENT. AMOUNT: 10ML DAILY. REASON FOR USE: GAS PERMEABLE CONTACT LENS CLEANING SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAN CARE CLEANING SOLUTION 3% HYDROGEN PEROXIDE LPN CIBA VISION 12211

    Patients

    Seq Age Sex Outcome Treatment
    1