BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 2554495 · Received June 11, 2010

    Report

    Report Number
    3006695864-2010-00068
    Event Type
    Injury
    Date Received
    June 11, 2010
    Date of Event
    November 20, 2009
    Report Date
    May 21, 2010
    Manufacturer
    AMO MANUFACTURING USA LLC
    Product Code
    LZS
    PMA / PMN Number
    K000327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SERVICE WAS NOT REQUESTED BY THE CLINIC FOR THIS ISSUE. CLINICAL DEVELOPMENT MANAGER AND AMO MEDICAL MONITOR DISCUSSED THE OUTCOMES WITH THE CLINIC. IT WAS DISCOVERED THAT THE SITE HAS TWO DOCTORS THAT WERE NOT CERTIFIED WITH THE USE OF THE VISX SYSTEM. CERTIFICATION TRAINING IS BEING SCHEDULED FOR THESE DOCTORS.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A PT WITH HYPEROPIA TREATED FOR AN I-SBK (SUB-BOWMANS KERATOMILEUSIS) LASER VISION CORRECTION IN THE RIGHT (OD) EYE PRESENTED AT A ONE MONTH POST-OPERATIVE EXAMINATION WITH AN UNDER CORRECTION OF 3/4 DIOPTER AND FLAP MICROSTRIAE. THE PT IS ALSO EXPERIENCING BLURRY AND DOUBLE VISION. THE PT'S BCVA IS 20/30 OD. THE PT HAD AN ENHANCEMENT TREATMENT PERFORMED IN THE OD EYE AT THREE MONTHS FOLLOWING THE INITIAL TREATMENT AND AT ONE MONTH POST ENHANCEMENT TREATMENT THE PT IS STILL EXPERIENCING DOUBLE IMAGES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other