BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASERSCAN LSX EXCIMER LASER (CE INTERNATIONAL)

    MDR report key: 284774 · Received July 5, 2000

    Report

    Report Number
    6000110-2000-00001
    Event Type
    Injury
    Date Received
    July 5, 2000
    Date of Event
    June 6, 2000
    Report Date
    July 3, 2000
    Manufacturer
    LASERSIGHT TECHNOLOGIES, INC.
    Product Code
    LZS
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR FELT THAT THE LASER BEAM WAS FIRING OFF CENTERED. IN DR'S OPINION, PT'S POST OPERATIVE BEST CORRECTED VISUAL ACUITY WAS LESS THAN ANTICIPATED. THE PT WAS RE-TREATED, OUTCOME OF THIS TREATMENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASERSCAN LSX EXCIMER LASER (CE INTERNATIONAL) EXCIMER LASER FOR CORRECTING REFRACTIVE ERRORS LZS LASERSIGHT TECHNOLOGIES, INC. 66040016 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *