BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 3908199 · Received June 5, 2014

    Report

    Report Number
    9610813-2014-00011
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    May 9, 2014
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K113168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT SAMPLE WAS NOT MADE AVAILABLE FOR EVALUATION. THE MANUFACTURING REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MANUFACTURING PROCESS. NO COMPLAINT OR MANUFACTURING TREND WAS 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 WAS SEEN FOR A CORNEAL ULCER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330257 DAILIES TOTAL 1 LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other