BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE IFS LASER

    MDR report key: 1891262 · Received October 27, 2010

    Report

    Report Number
    3006695864-2010-00110
    Event Type
    Injury
    Date Received
    October 27, 2010
    Report Date
    June 20, 2010
    Manufacturer
    AMO MANUFACTURING USA, LLC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: AMO FIELD SERVICE ENGINEERS AND CLINICAL DEVELOPMENT SPECIALISTS HAD BEEN ON SITE TO CHECK, INVESTIGATE, AND EVALUATE THE INTRALASE LASER IN RELATIONSHIP TO THE REPORTED EVENTS. ADDITIONALLY RETRAINING OF STAFF REGARDS TO AND USE OF THE LASER WAS PERFORMED. DURING DISCUSSION WITH THE CLINIC ABOUT POTENTIAL ROOT CAUSES FOR THE DLK CASES IT WAS REVEALED THAT THE USER FACILITY'S STERILIZATION SYSTEM (STATIM) WAS MOST LIKELY THE CAUSE FOR DLKS GIVEN THAT DLK CASES WERE ALSO THE RESULT WHEN MICROKERATOME (STERILIZED ON SITE) WAS USED TO CUT THE FLAPS.

    Description of Event or Problem · 1

    INTRALASE FS LASER WAS USED FOR CREATION OF FLAP. SEVERAL PATIENTS WHICH EXPERIENCED DLK (DIFFUSE LAMELLAR KERATITIS) STAGES 1, 2, 3 OR 4. AMO REQUESTED PATIENT SPECIFIC DATA FOR ALL THESE EVENTS FROM THE HOSPITAL. THIS REPORT IS FOR A SPECIFIC PATIENT THAT EXPERIENCED DLK STAGE 2. PRE-OP VA = 10/10, POST-OP VA = 8/10.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other