BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 2554511 · Received June 11, 2010

    Report

    Report Number
    3006695864-2010-00067
    Event Type
    Injury
    Date Received
    June 11, 2010
    Date of Event
    August 12, 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 FRO AN I-SBK (SUB-BOWMANS KERATOMILEUSIS) LASER VISION CORRECTION IN BOTH EYES PRESENTED AT A TWO MONTH POST-OPERATIVE EXAMINATION WITH MILD DLK AND EPI-INGROWTHS IN THE LEFT EYE (OS) AND A REFRACTION OF - .75 DIOPTER IN THE RIGHT EYE (OD) AND -01.00 DIOPTER IN THE LEFT EYE (OS). THE PT HAD AN ENHANCEMENT TREATMENT PERFORMED IN THE OD EYE AT FOUR MONTHS FOLLOWING THE INITIAL TREATMENT. AT THE FOUR MONTH POST ENHANCEMENT EXAM THE PT'S REFRACTION WAS +0.50 IN THE OD EYE. A CENTRAL ISLAND WAS OBSERVED IN THE OS EYE. THE PT'S POST-OP BCVA AND UCVA IS 20/25/ OD AND 20/40 OS.

    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 55 YR