BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 3827764 · Received May 8, 2014

    Report

    Report Number
    9610813-2014-00008
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K113168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    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 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 PATIENT PRESENTED WITH A CORNEAL ULCER IN THE LEFT EYE. THE LOCATION OF THE ULCER WAS PERIPHERAL AND THERE WAS SCARRING WHICH WAS LESS THAN 1MM. THE PATIENT DID NOT EXPERIENCE ANY VISION LOSS. THE EVENT HAS RESOLVED AND THE PATIENT HAS RESUMED LENS WEAR WITH THE PREVIOUS BRAND OF LENSES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014 FROM THE ECP STATING THE ECP WAS ONLY THE PATIENT FOR FOLLOW UP AFTER HE HAD BEEN TREATED ELSE WHERE WHILE ON VACATION, AND AT THIS TIME THE EVENT HAD ALREADY RESOLVED. THIS ECP HAS NO FURTHER DETAILS THAT SHE CAN PROVIDE AS SHE DID NOT TREAT THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO SEE IF CONTACT TO THE TREATING PHYSICIAN IS POSSIBLE. NO ADDITIONAL HAD BEEN RECEIVED AS OF YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278158 DAILIES TOTAL 1 LENS, CONTAC (DISPOSABLE) MVN CIBA VISION GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other