BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS DAILIES VISITINT (AQUA RELEASE)

    MDR report key: 2800970 · Received October 18, 2012

    Report

    Report Number
    1065835-2012-00010
    Event Type
    Injury
    Date Received
    October 18, 2012
    Report Date
    September 21, 2012
    Manufacturer
    CIBA VISION CORPORATION
    Product Code
    LPL
    PMA / PMN Number
    K984273
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. THE COMPLAINT PRODUCT WAS NOT RETURNED AND RETAIN SAMPLES WERE NOT AVAILABLE IN INVENTORY FOR EVALUATION. THERE WERE 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

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN AMOEBIC INFECTION ASSOCIATED WITH CONTACT LENS WEAR. THE PATIENT BEGAN WITH A SORE EYE (WHICH EYE IS UNSPECIFIED) TWO WEEKS AGO AND WENT TO THE DOCTOR WHO DIAGNOSED THE PATIENT WITH CONJUNCTIVITIS. THE PATIENT THEN WENT ON A BUSINESS TRIP FOR TWO DAYS AND DURING THAT TIME FOUND HIS EYE IN SO MUCH PAIN THAT HE HAD TO SPEND A DAY IN BED. THE NEXT DAY HE WENT TO A PHARMACY WHERE HE WAS ADVISED TO GO TO THE HOSPITAL. THE HOSPITAL ORIGINALLY DIAGNOSED THE ISSUE AS A (B)(6) INFECTION AND ARRANGED A FOLLOW-UP CONSULTANT APPOINTMENT. DURING THE FOLLOW-UP CONSULTANT APPOINTMENT, THE PATIENT WAS THEN DIAGNOSED WITH AND IS BEING TREATED FOR ACANTHAMOEBA KERATITIS, AS WELL AS A FUNGAL INFECTION. THE TREATMENT IS UNSPECIFIED. THE LATEST INFORMATION RECEIVED STATES THAT THE PATIENT IS IMPROVING AND HAS ANOTHER HOSPITAL APPOINTMENT SCHEDULED FOR (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS DAILIES VISITINT (AQUA RELEASE) LENSES, SOFT CONTACT, DAILY WEAR LPL CIBA VISION CORPORATION A0239505

    Patients

    Seq Age Sex Outcome Treatment
    1 Other