BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 3190187 · Received June 21, 2013

    Report

    Report Number
    9610813-2013-00009
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 13, 2013
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K113168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE LOT NUMBER IS UNKNOWN, THEREFORE, FURTHER INVESTIGATION CANNOT BE PERFORMED. A TREND RELATED INVESTIGATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EYE CARE PROFESSIONAL THAT A PATIENT DEVELOPED A CORNEAL ULCER IN HIS RIGHT EYE DURING DAILY DISPOSABLE CONTACT LENS USE. THE PATIENT BEGAN USING DAILY DISPOSABLE LENSES ON (B)(6) 2013. THE ULCER WAS DIAGNOSED ON (B)(6) 2013, DURING A CONTACT LENS REFITTING (CLR) EXAM. THE PATIENT PREVIOUSLY WORE A TWO WEEK CONTACT LENSES AND USED DISINFECTING CONTACT LENS SOLUTION IN GOOD COMPLIANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ECP BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282328 DAILIES TOTAL 1 LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other