BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 5793032 · Received July 13, 2016

    Report

    Report Number
    3006695864-2016-00714
    Event Type
    Injury
    Date Received
    July 13, 2016
    Date of Event
    June 3, 2016
    Report Date
    July 13, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LASER MACHINE WAS EXAMINED AND TESTED BY AN AMO FIELD SERVICE SPECIALIST (FSS). THE FSS FOUND NO ISSUES WITH THE LASER. THE FSS PERFORMED A 3 MONTH PREVENTATIVE MAINTENANCE. IN ADDITION, THE FSS CHECKED THE AUTOCORRELATION, SPOT CAMERA DATA AND OSCILLATOR BI-STABILITY REGION. THE FSS PERFORMED A FIELD SERVICE CHECKLIST. THE SYSTEM WAS VERIFIED FOR ALL MODES OF OPERATIONS AND CALIBRATIONS. THE SYSTEM MET AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT EXPERIENCED DIFFUSE LAMELLAR KERATITIS (DLK) ON THE BOTH EYES (OU) AFTER A LASER PROCEDURE THAT WAS PERFORMED ON (B)(6) 2016. A DESCRIPTION FROM THE SURGERY CENTER INDICATED THE SURGEON WAS SEEING PERIPHERAL LAMELLAR INFLAMMATION FOR ABOUT 2 WEEKS. THE SURGEON STATED THE INFLAMMATION RESPONDS TO INCREASE IN STEROID DROPS. IN ADDITION, THE SURGEON DECREASED THE ENERGY FROM .80 BED ENERGY TO .75 BED ENERGY. AN ABBOTT MEDICAL OPTICS' APPLICATION SUPPORT MANAGER (ASM) DISCUSSED THE INFLAMMATION COULD ALSO BE DUE TO EXTERNAL SOURCES, SUCH AS INSTRUMENTAL CLEANING AND STERILIZATION, EYE DROPS AND GLOVE USE. AT ONE DAY POST OP, THE PATIENT HAD DEVELOPED A MILD CASE OF DLK. THE INFLAMMATION WAS NOTED ON THE OUTSIDE VISUAL AXIS. THE PATIENT HAD AN INCREASE IN PRED FORTE (PF) TO EVERY 2 HOURS FOR BOTH EYES (OU) AND AFTERWARDS FOR 4 TIMES A DAY. AT SIX DAY POST OP, THE PATIENT'S DLK WENT FROM MILD TO A TRACE OF DLK. THE PF WAS TO BE CONTINUED TO 4 TIMES A DAY FOR 2 DAYS. THIS IS FOUR OF FOUR REPORTS. PRE-OP BCVA OU FROM (B)(6) 2016 20/20- POST-OP BCVA OU FROM (B)(6) 2016: 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444535 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention