BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISX EXCIMER LASER

    MDR report key: 2560016 · Received April 12, 2010

    Report

    Report Number
    3006695864-2010-00028
    Event Type
    Other
    Date Received
    April 12, 2010
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    PMA / PMN Number
    K000327
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN AMO FIELD SERVICE TECHNICIAN EXAMINED THE SYSTEM AT THE CUSTOMER LOCATION AND FOUND THAT THE THYRATRON HAD FAILED. THE THYRATRON WAS REPLACED ALONG WITH THE TRIGGER BOARD. THE SYSTEM WAS CALIBRATED AND VOLTAGES ADJUSTED. THE SYSTEM MET THE DEVICES SPECIFICATION UPON COMPLETION OF SERVICE. HIGH VOLTAGE SWITCHING DEVICE (THYRATRON) AND TRIGGER BOARD.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT DURING A PRK TREATMENT THE LASER SHUT DOWN WITH ABOUT 5 SECONDS LEFT IN THE TREATMENT ON THE PT'S LEFT (OS) EYE. THE SURGEON COMPLETED THE TREATMENT AT A DIFFERENT SITE ON THE SAME DAY WITHOUT FURTHER INCIDENT. AT 27 DAYS THE POST-OP EXAMINATION REVEALED THE PT'S BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/25 IN THE OS EYE AND 20/30 IN THE RIGHT (OD) EYE. PTS TREATED FOR PRK HAVE AN EXPECTED SLOWER RECOVERY. THE PT'S REPORTED VISUAL ACUITY IS NOT UNUSUAL FOR PRK TREATMENTS AT ONE MONTH FOLLOWING TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1