BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 2491959 · Received March 14, 2012

    Report

    Report Number
    3006695864-2012-00047
    Event Type
    Injury
    Date Received
    March 14, 2012
    Date of Event
    January 20, 2012
    Report Date
    February 13, 2012
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    PMA / PMN Number
    K000327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN AMO FIELD SERVICE ENGINEER EXAMINED THE LASER AT THE CUSTOMER'S LOCATION. FIELD SERVICE ENGINEER REPLACED AND ALIGNED THE OPTICAL LENSES AS PART OF NORMAL SYSTEM CHECKS. A CLINICAL DEVELOPMENT MANAGER ALSO WENT TO THE CUSTOMER'S SITE AND PROVIDED SURGICAL SUPPORT AND TRAINING TO THE CLINIC STAFF AND DISCOVERED THAT THE CALIBRATION READINGS HAD BEEN READ INCORRECTLY BY THE LASER OPERATOR SINCE (B)(4) 2012. CLINICAL DEVELOPMENT MANAGER RETRAINED THE OPERATOR ON THE CALIBRATION PROCESS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A PATIENT WAS UNDER-CORRECTED IN THE RIGHT EYE FOLLOWING A LASER VISION CORRECTION PROCEDURE. THE PATIENT'S PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) IN EACH EYE (RIGHT EYE OD/LEFT EYE OS) WAS 20/20. POST OP BCVA AT ONE MONTH EXAM IS 20/40 IN THE RIGHT EYE AND 20/25 IN THE LEFT EYE.

    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 52 YR Other