BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESHLOOK ONE-DAY

    MDR report key: 3824396 · Received May 14, 2014

    Report

    Report Number
    9610813-2014-00009
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    May 21, 2013
    Report Date
    April 15, 2014
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K050213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. NO ROOT CAUSE COULD BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FRENCH HEALTH AUTHORITY ON (B)(6) 2014 THAT A PATIENT EXPERIENCED A SERIOUS CORNEAL ABSCESS ON THE RIGHT EYE AFTER USING COSMETIC DAILY DISPOSABLE CONTACT LENSES ON (B)(6) 2013. THE PATIENT WAS HOSPITALIZED. FORTIFIED EYE DROP TREATMENTS WERE APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287922 FRESHLOOK ONE-DAY LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O