BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 1950570 · Received November 17, 2010

    Report

    Report Number
    3006695864-2010-00131
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 25, 2010
    Manufacturer
    AMO MANUFACTURING USA LLC
    Product Code
    LZS
    PMA / PMN Number
    K000327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO CLINICAL SUPPORT OR SERVICE WAS REQUESTED. CUSTOMER REPORTING INCIDENT ONLY.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT THE TREATING SURGEON MADE A TRANSPOSITION ERROR ON A CONVENTIONAL MONOVISION TREATMENT PLAN FOR A PATIENT UNDERGOING LASER VISION CORRECTION. THE TREATMENT AFFECTED THE LEFT EYE. PATIENT WAS UNDERCORRECTED BY 5 DIOPTERS AND IS CURRENTLY 20/30 IN THE OS EYE. THE PATIENT WAS REFERRED TO A DIFFERENT SURGEON FOR FOLLOW-UP. NO FURTHER INFORMATION AVAILABLE ON THE PATIENT'S CURRENT STATUS.

    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 53 YR Other