BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 4223253 · Received October 29, 2014

    Report

    Report Number
    9610813-2014-00036
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 5, 2014
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K113168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. UNOPENED PRODUCT FROM THE SAME LOT WAS RETURNED AND FOUND TO BE WITHIN SPECIFICATION. THERE WAS NO NONCONFORMITY OR DEVIATIONS DURING THE MANUFACTURING PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    AS INITIALLY REPORTED BY AN EYE CARE PROFESSIONAL (ECP) ON (B)(6) 2014, A PATIENT EXPERIENCED AN UNSPECIFIED EYE INFECTION AND WAS TREATED IN AN URGENT CARE SETTING. ADDITIONAL INFO RECEIVED BY THE REPORTING ECP ON (B)(6) 2014 CLARIFIED THAT THE EVENT OCCURRED ON (B)(6) 2014 AND INVOLVED THE LEFT EYE. THE PATIENT EXPERIENCED SYMPTOMS OF SEVERE PAIN/DISCOMFORT, SEVERE REDNESS, AND MUCOPURULENT DISCHARGE. A BIOPSY WAS PERFORMED, BUT THE RESULTS WERE NOT KNOWN BY THE ECP. IT WAS REPORTED THAT A CORNEAL ULCER WITH AN UNSPECIFIED LOCATION WAS SEEN UPON EXAMINATION AT THE URGENT CARE FACILITY. THE PATIENT WAS PRESCRIBED HOURLY DOSING OF UNSPECIFIED ANTIBIOTICS AND CEASED CONTACT LENS WEAR DURING THIS EVENT. IT HAS BEEN REPORTED THAT THE EVENT HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691004 DAILIES TOTAL 1 LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH N1118563

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other