BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4-IR-ETL EXCIMER LASER

    MDR report key: 2936108 · Received January 30, 2013

    Report

    Report Number
    3006695864-2013-00022
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 3, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE OF EVENT IS UNKNOWN. DATE PROVIDED IS AN APPROXIMATE DATE.INFORMATION IN SECTION F10 IS PROVIDED BY THE MANUFACTURERTHE 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. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AT THE ONE DAY POST OP EXAMINATION A LASER VISION CORRECTION PATIENT PRESENTED WITH TRACE DIFFUSE LAMELLAR KERATITIS (DLK) IN THE LEFT EYE. THE PATIENT WAS TREATED WITH TOPICAL STEROIDS. THE PATIENT''S POST OP VISUAL ACUITY WAS NOT PROVIDED HOWEVER THE PATIENT WAS REPORTED AS BEING HAPPY WITH THEIR VISUAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40665 STAR S4-IR-ETL EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS 0030-4864

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AMO INTRALASE FEMTOSECOND LASER