BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 3940392 · Received June 18, 2014

    Report

    Report Number
    9610813-2014-00013
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    May 20, 2014
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K113168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT SAMPLE WA SNOT 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 HAD TO SEEK URGENT MEDICAL ATTENTION IN (B)(6) 2014 AFTER EXPERIENCING PROBLEMS WITH THE RIGHT EYE. THE ECP FOUND THAT 2 LENSES WERE PLACED IN THE SAME EYE. THE ECP DID NOT KNOW HOW LONG THE PATIENT HAD THE DOUBLE LENS IN THE EYE, BUT SUSPECTED IT WAS WORN FOR 3 DAYS. THE PATIENT WAS HOSPITALIZED DUE TO INFECTIOUS KERATITIS. THE PATIENT WAS PRESCRIBED OFTAQUIX EYE DROPS. CURRENTLY THE EVENT HAS RESOLVED AND LENS WEAR HAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357603 DAILIES TOTAL 1 LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O