BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 2161959 · Received March 29, 2011

    Report

    Report Number
    3006695864-2011-00021
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 1, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    PMA / PMN Number
    K000327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE WAS NOT REQUESTED FOR THIS EVENT HOWEVER THE AMO FIELD SERVICE ENGINEER DID EXAMINE THE EQUIPMENT A FEW DAYS AFTER THE TREATMENT FOR A DIFFERENT ISSUE. THE FIELD SERVICE ENGINEER PERFORMED TRACKER CALIBRATIONS AND OPTICS ADJUSTMENTS AND REPORTED THERE WERE NO ISSUES WITH THE EQUIPMENT. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT A PATIENT TREATED FOR LASIK VISION CORRECTION PRESENTED AT THE TEN DAY POST OPERATIVE EXAMINATION WITH A BEST CORRECTED VISUAL ACUITY OF 20/50 IN BOTH EYES. THE DOCTOR FURTHER REPORTED THAT THE VISION IS UNCORRECTABLE. THE PATIENT WAS EXAMINED AT THE ONE MONTH POST-OP FOLLOW-UP AND THE VISUAL ACUITY WAS REPORTED AS UNCHANGED. THE DOCTOR INDICATED THAT THE PATIENT IS BEING SENT FOR A SECOND OPINION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other