BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR EXCIMER LASER

    MDR report key: 2962233 · Received February 14, 2013

    Report

    Report Number
    3006695864-2013-00048
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMO FIELD SERVICE ENGINEER EVALUATED THE SYSTEM AT THE CUSTOMER'S LOCATION AND NOTED THAT THE ROOM'S HUMIDITY WAS VERY LOW. THE CLINIC WAS ADVISED OF THE RESULTS. FIELD SERVICE PERFORMED CALIBRATIONS AND ADJUSTMENTS TO THE SYSTEM. THE AMO CLINICAL DEVELOPMENT MANAGER ALSO WORKED WITH THE CLINIC AND EVALUATED THE CALIBRATION PROFILE FROM THE TREATMENT DAYS. THE SYSTEM WAS FOUND TO BE WITHIN CALIBRATION ON THESE DAYS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT UNDERWENT A PRK (PHOTOREFRACTIVE KERATECTOMY) TREATMENT IN EACH EYE AND PRESENTED AT A POST OPERATIVE EXAM WITH CENTRAL ISLANDS AND POOR VISION. THE PATIENT'S POST OP BEST CORRECTED VISUAL ACUITY IS 20/30 AND 20/50 .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64745 STAR S4 IR EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS STAR S4 IR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other