BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESHLOOK ONE-DAY

    MDR report key: 2921733 · Received January 15, 2013

    Report

    Report Number
    9610813-2013-00001
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 17, 2012
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K050213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    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 FROM THE ECP OFFICE THAT A PATIENT EXPERIENCED A CORNEAL ULCER ASSOCIATED WITH CONTACT LENS WEAR. UPON FURTHER FOLLOW-UP WITH THE PATIENT, SHE REPORTED THAT SHE IS A FIRST TIME USER AND EXPERIENCED A TEARING AND BURNING SENSATION. THE PATIENT CLEANED HER HANDS AND THE LENS WITH SALINE SOLUTION THEN THE PATIENT NOTICED A WHITE "PELLICLE" ON HER LEFT EYE AFTER WEARING THE LENSES FOR ABOUT 6 HOURS. THE PATIENT VISITED THE DOCTOR, WHO DIAGNOSED HER WITH AN ULCER DUE TO THE LENS WEAR AND PRESCRIBED HER CEPHALOTHIN EYE DROPS AND GENTAMICIN EYE DROPS FOR 6 DAYS AND THE ECP RECOMMENDED THAT THE PATIENT USE THE DROPS UNTIL SHE FULLY RECOVERED. HOWEVER, THE PATIENT STOPPED USING THE DROPS AFTER THE 6TH DAY, AND ONLY RECOVERED PARTIALLY. THE CONSUMER STILL HAS SOME PAIN AND TEARING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22947 FRESHLOOK ONE-DAY LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other