BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 2140293 · Received June 15, 2011

    Report

    Report Number
    3006695864-2011-00055
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 17, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT REQUEST FIELD SERVICE TO INSPECT THE EQUIPMENT. REQUESTED MEDICAL MONITOR REVIEW OF PATIENT DATA. THE AMO MEDICAL MONITOR'S ASSESSMENT OF THE PATIENT CHART INDICATED THAT THE TOPOGRAPHY FOR THE PATIENT REVEALED TRUNCATED ABLATIONS IN BOTH EYES AND DETERMINED THAT THE TREATMENTS WERE TRUNCATED DUE TO THE NASAL HINGE OF THE FLAP IMPINGING ON THE ABLATION ZONE OR FLUID ACCUMULATION NEAR THE HINGE. THE MOST LIKELY CAUSE OF THE CENTRAL UNDER ABLATION IS CENTRAL FLUID FROM INTRAOPERATIVE PACHYMETRY. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT A PATIENT TREATED FOR LASER VISION CORRECTION PRESENTED AT A POST-OPERATIVE EXAMINATION WITH A DECENTERED ABLATION AND MILD CENTRAL STEEPENING IN BOTH EYES. THE PATIENT ALSO REPORTED EXPERIENCING GLARE/HAZE IN THE LEFT EYE. THE PATIENT'S POST-OP UCVA IS 20/20 IN THE RIGHT EYE AND 20/15 IN THE LEFT EYE AND THE BCVA IS 20/20 IN BOTH THE RIGHT AND LEFT EYE. THE CUSTOMER USES A MECHANICAL BLADE TO CUT THE FLAPS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other