BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4-IR-ETL EXCIMER LASER

    MDR report key: 2962244 · Received February 14, 2013

    Report

    Report Number
    3006695864-2013-00050
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 23, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINIC IS REPORTING THIS EVENT ONLY AND DOES NOT SUSPECT THE EQUIPMENT AS THE SOURCE OF THE DLK. FIELD SERVICE WAS NOT REQUESTED. THE CLINIC IS EXPERIENCING A CLUSTER OF DLK CASES AND THE AMO CLINICAL DEVELOPMENT MANAGER IS ASSISTING THE CUSTOMER WITH THEIR INVESTIGATION INTO THE CAUSE OF THE DLK. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT (B)(4) TREATED FOR LASER VISION CORRECTION ENHANCEMENT PRESENTED AT A POST OP EXAM WITH TRACE DIFFUSE LAMELLAR KERATITIS (DLK). PATIENTS WERE TREATED WITH TOPICAL STEROIDS AND HAVE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64483 S4-IR-ETL EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS S4-IR-ETL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention