BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 2082649 · Received April 27, 2011

    Report

    Report Number
    3006695864-2011-00032
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    February 11, 2011
    Report Date
    April 3, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE WAS NOT REQUESTED FOR THIS EQUIPMENT. A PREVENTATIVE MAINTENANCE WAS PERFORMED ON THIS EQUIPMENT IN (B)(6) 2011. NO ISSUES WERE DETECTED. AN AMO CLINICAL DEVELOPMENT MANAGER VISITED THE CUSTOMER AND REVIEWED ALL THEIR PROCESSES INCLUDING STERILIZATION AND CLEANING. IT WAS DISCOVERED THAT THE CUSTOMER WAS USING GLOVES THAT ARE NOT RECOMMENDED FOR LASER VISION TREATMENTS AND THEY WERE ADVISED TO CHANGE TO A DIFFERENT TYPE OF GLOVE. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED A PATIENT PRESENTED WITH DIFFUSE LAMELLAR KERATITIS (DLK) IN BOTH EYES (OU) FOLLOWING LASER VISION CORRECTION TREATMENT. THE FLAPS WERE LIFTED AND RINSED TWO AND THREE WEEKS POST OP AND THE PATIENT WAS PRESCRIBED PRE FORTE OU. THE PATIENT'S UNCORRECTED VISUAL ACUITY IS 20/40+2 OD AND 20/50 OS. CORRECTED VISUAL ACUITY IS 20/20-2 OU. THE CLINIC INDICATED THAT THEY USED A MICROKERATOME TO CUT THE FLAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISX EXCIMER LASER LZS AMO MANUFACTURING USA, LLC STAR S4 IR ETL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention