BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION 4000

    MDR report key: 1000920 · Received February 20, 2008

    Report

    Report Number
    1061857-2008-00019
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    October 26, 2007
    Report Date
    January 21, 2008
    Manufacturer
    ALCON - ORLANDO TECHNOLOGY CENTER
    Product Code
    LZS
    PMA / PMN Number
    P970043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH GRADE 2 DIFFUSE LAMELLAR KERATITIS (DLK) FOLLOWING AN ENHANCEMENT PROCEDURE AND WAS TREATED WITH TOPICAL CORTICOSTEROIDS. ADDITIONAL INFORMATION PROVIDED INDICATES BOTH EYES WERE AFFECTED. THIS REPORT IS FOR THE LEFT EYE, THE RIGHT EYE IS BEING REPORTED UNDER MANUFACTURER REPORT# 1061857-2008-00017. THE LATEST INFORMATION INDICATES THE OUTCOME OF THE EVENT AND THE PROGNOSIS OF THE PATIENT ARE POOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM LZS ALCON - ORLANDO TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention