BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 2421081 · Received January 13, 2012

    Report

    Report Number
    3006695864-2011-00157
    Event Type
    Injury
    Date Received
    January 13, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 16, 2011
    Manufacturer
    AMO MANUFACTURING USA LLC
    Product Code
    LZS
    PMA / PMN Number
    K000327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN AMO FIELD SERVICE ENGINEER EXAMINED THE LASER AT THE CUSTOMER LOCATION AND NO ISSUES WERE FOUND THAT WERE RELATED TO THE REPORTED EVENT. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT THEY WERE SEEING OVER CORRECTIONS IN MULTIPLE PATIENTS TREATED FOR LASER VISION CORRECTION AND WITH TWO DIFFERENT DOCTORS. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CLINIC HOWEVER AS OF THIS DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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 Other