BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS DAILIES VISITINT AQUA RELEASE

    MDR report key: 3052946 · Received April 4, 2013

    Report

    Report Number
    1065835-2013-00003
    Event Type
    Injury
    Date Received
    April 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    CIBA VISION CORPORATION
    Product Code
    LPL
    PMA / PMN Number
    K072777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING INVESTIGATION IS UNDERWAY. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION REPORT. INTERNAL CONTROL NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2013 BY EYE CARE PROFESSIONAL THAT THE PATIENT HAD A LENS THAT TORE DURING WEAR AND CAUSED CORNEAL EROSION. ACCORDING TO THE OPHTHALMOLOGIST, THE PATIENT CAN NOT WEAR CONTACT LENSES FOR FOUR MONTHS. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 THAT THE CORRECT TRANSLATION OF THE INITIAL REPORT IS THAT THE PATIENT WAS INFORMED BY HER EYE CARE PROFESSIONAL THAT SHE HAD AN ULCER ON THE CORNEA. THE OPTICIAN SPOKE WITH THE PATIENT AND REQUESTED THEIR MEDICAL RECORDS FROM THE HOSPITAL, THE PATIENT HAS NOT RETURNED FOR FURTHER EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139359 FOCUS DAILIES VISITINT AQUA RELEASE LENS, CONTACT DISPOSABLE LPL CIBA VISION CORPORATION A0307465

    Patients

    Seq Age Sex Outcome Treatment
    1 Other