BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLEAR CARE

    MDR report key: 3092154 · Received April 29, 2013

    Report

    Report Number
    MW5030012
    Event Type
    Other
    Date Received
    April 29, 2013
    Date of Event
    April 28, 2013
    Report Date
    April 29, 2013
    Manufacturer
    CIBA VISION
    Product Code
    LPN
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CIBA VISION CLEAR CARE IS NOT CLEARLY MARKED OR IT SHOULD ONLY BE HANDED OUT IF GIVEN WITH A VERBAL IN PERSON EXPLANATION ON USES AND DANGERS OF MISUSE. THIS PRODUCT IS UNNECESSARILY DANGEROUS AND CONFUSING AS TO LABELING AND HIGH POTENTIAL FOR MISTAKE IN USAGE. DOSE OR AMOUNT: STORED IN FLAT CONTACT LENSE, FREQUENCY: ONCE, ROUTE: OPHTHALMIC. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184656 CLEAR CARE NONE LPN CIBA VISION 13283

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR