BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4-IR-ETL EXCIMER LASER

    MDR report key: 2911656 · Received January 11, 2013

    Report

    Report Number
    3006695864-2013-00003
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 18, 2012
    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

    INFORMATION IN SECTION F10 IS PROVIDED BY THE MANUFACTURER THE CLINIC DOES NOT SUSPECT THAT THE EQUIPMENT IS THE CAUSE OF THEIR DLK. THE CLINIC HAS BEEN EXPERIENCING A CLUSTER OF DLK CASES AND THE AMO CLINICAL DEVELOPMENT MANAGER IS ASSISTING THEM WITH THEIR INVESTIGATION. THE CLINIC PLANS ON INSTALLING HEPA FILTERS IN THE FUTURE. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT TWO PATIENTS TREATED FOR LASER VISION CORRECTION ON THE SAME SURGERY DAY PRESENTED WITH 1+ DLK (DIFFUSE LAMELLAR KERATITIS) AT THE POST-OP EXAMINATION. THE CLINIC REPORTED THAT ALL CASES OF DLK HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17192 STAR S4-IR-ETL EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS STAR S4-IR-ETL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention