BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS LASER

    MDR report key: 2482255 · Received March 7, 2012

    Report

    Report Number
    3006695864-2012-00037
    Event Type
    Injury
    Date Received
    March 7, 2012
    Date of Event
    November 19, 2011
    Report Date
    February 7, 2012
    Manufacturer
    AMO MANUFACTURING USA, LLC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO EVALUATE THE SYSTEM AND INDICATED THAT SEVERAL TEST PROCEDURES WERE PERFORMED IN GELS. THE FSE FOUND THAT THE SYSTEM FUNCTIONED PROPERLY AND THE GEL CHARACTERISTICS LOOKED GOOD. THE FSE ALSO STATED THAT THE MAX ENERGY WAS STABLE. THE FSE ALSO STATED THAT SHE PROACTIVELY REALIGNED THE STRETCHER AND COMPRESSOR ON THE LASER ENGINE, PERFORMED AUTO CORRELATION TO VERIFY PULSE WIDTH, AND PREFORMED PREVENTIVE MAINTENANCE WITH NO OBSERVATIONS. PRIOR TO LEAVING SHE INDICATED THAT THE SYSTEM MEETS ALL AMO SPECIFICATIONS.

    Description of Event or Problem · 1

    THE INTRALASE FEMTOSECOND LASER WAS USED TO CREATE A CORNEAL FLAP FOR LASIK SURGERY ON (B)(6), 2011. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER INDICATING THAT THE PATIENT WAS DIAGNOSED WITH DIFFUSED LAMELLAR KERATITIS (DLK) ON (B)(6), 2011, BOTH EYES (OU). A LIFT AND RINSE WAS NOT REQUIRED TO RESOLVE THE DLK. HOWEVER, THE DLK LASTED OVER ONE MONTH, RESOLVING ON (B)(6), 2012 USING STANDARD TREATMENT OF CARE (PRED FORTE AND DUREZOL). THE PATIENT'S PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY WAS 20/20 AND THEIR POST-OPERATIVE VISUAL ACUITY WAS 20/20 -1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS LASER FEMTOSECOND LASER HNO AMO MANUFACTURING USA, LLC. R20002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention