BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 2665388 · Received July 19, 2012

    Report

    Report Number
    9610813-2012-00008
    Event Type
    Injury
    Date Received
    July 19, 2012
    Date of Event
    June 19, 2012
    Report Date
    June 19, 2012
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 UNK, THEREFORE, FURTHER INVESTIGATION CANNOT BE PERFORMED. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A F/U MEDWATCH WILL BE FILED. THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT DAILIES VISITINT AQUACOMFORT PLUS THAT IS SOLD IN THE U.S UNDER PMA/510 (K) # K984273. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN EYE CARE PROFESSIONAL THAT THE PT DEVELOPED AN INFECTIOUS KERATITIS IN HIS RIGHT EYE, LOCATED AT THE 12 O'CLOCK POSITION ABOUT 5 MM FROM THE LIMBUS FOLLOWING CONTACT LENS WEAR. CORNEAL INFILTRATES WERE NOTED APPROXIMATELY 2 MM IN SIZE AND AN ANTERIOR CHAMBER REACTION WAS NOTED. THE PT REPORTED MODERATE PAIN. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other