BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 2161957 · Received May 17, 2011

    Report

    Report Number
    3006695864-2011-00048
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 28, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMO FIELD SERVICE SPECIALIST PERFORMED AN INSPECTION OF THE EQUIPMENT AND NO ISSUES WERE FOUND WITH THE OPERATION OF THE EQUIPMENT. THE SYSTEM MET THE SPECIFICATIONS FOR THE DEVICE. THE CLINICAL DEVELOPMENT MANAGER CONTACTED THE CUSTOMER FOR ADDITIONAL INFORMATION ON THE PATIENTS; HOWEVER, THE CLINIC HAS NOT RESPONDED TO THE REQUESTS. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED HE HAD SEVERAL PATIENTS WITH RESIDUAL ASTIGMATISM FOLLOWING LASIK VISION CORRECTION. THE DOCTOR HAS NOT PROVIDED ANY FURTHER INFORMATION ON THE PATIENTS.

    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 Required Intervention