BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 3779223 · Received April 16, 2014

    Report

    Report Number
    9610813-2014-00007
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 20, 2014
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K113168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN REC'D FOR ANALYSIS. THE LOT NUMBER IS UNK, THEREFORE, FURTHER INVESTIGATION CANNOT BE PERFORMED. A TREND RELATED INVESTIGATION WAS PERFORMED. NO TREND COULD BE IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EYE CARE PROFESSIONAL (ECP) THAT A PT WAS DIAGNOSED WITH A CORNEAL ULCER IN THE LEFT EYE WHILE WEARING TRIAL LENSES. THE PT WAS REFERRED TO A CORNEAL SPECIALIST. ADD'L INFO REC'D FROM THE ECP VIA AN ADVERSE EVENT FORM ON (B)(6) 2014, STATING THAT THE PT WAS DIAGNOSED WITH A CORNEAL ULCER IN THE LEFT EYE ON (B)(6) 2014. THE PT EXPERIENCED MILD PAIN/DISCOMFORT, MILD REDNESS, WATERY DISCHARGE, AND NO ANTERIOR CHAMBER REACTION. THE LOCATION OF THE ULCER IS UNSPECIFIED. THERE WAS ONE PERIPHERAL INFILTRATE PRESENT UP TO 1MM IN SIZE. THERE WAS MILD TO MODERATE CORNEAL STAINING THAT COVERED <50% OF THE CORNEA. THERE WAS MILD SCARRING NOTED. THE PT WAS PRESCRIBED OFLOXACIN 0.3% OPH SOLUTION LGT OS Q30 MIN X 2D Q4H POST BEDTIME, 1GT OS QIH X 4 DAYS, AND 1GT OS QID X 2 DAYS. THE PT HAD A F/U APPOINTMENT SCHEDULED ON (B)(6) 2014. THE PT HAS NOT RESUMED LENS WEAR AT THIS TIME, AND THE ULCER HAS NOT HEALED. ADD'L INFO HAS BEEN REQUESTED BUT NOT YET REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234054 DAILIES TOTAL 1 LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other