BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADAR6000 SYSTEM

    MDR report key: 844017 · Received April 25, 2007

    Report

    Report Number
    1061857-2007-00177
    Event Type
    Injury
    Date Received
    April 25, 2007
    Date of Event
    July 14, 2006
    Report Date
    March 26, 2007
    Manufacturer
    ALCON - ORLANDO TECHNOLOGY CENTER
    Product Code
    DZS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION, INCLUDING ROOT CAUSE DETERMINATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A SYSTEM OPERATOR PROVIDED A SPREADSHEET OF PATIENT DATA FOR ANALYSIS AND ASSISTANCE IN PREPARATION OF A PLATFORM PRESENTATION. UPON REVIEW OF THE DATA, THIS PATIENT WAS FOUND TO EXHIBIT AN INCREASE IN MRSE (MANIFEST REFRACTION SPHERICAL EQUIVALENT) IN THE RIGHT EYE AT THE 6-WEEK POST-OPERATIVE EXAM. PATIENT RECORDS HAVE BEEN RECEIVED AND INDICATE AT 7 MONTHS POST-OP, THIS PATIENT EXHIBITS A DECREASE IN BCVA IN BOTH EYES. THE RIGHT EYE WAS REPORTED UNDER MANUFACTURER REPORT #1061857-2006-00222. THIS REPORT IS FOR THE LEFT EYE. AT THE LATEST POST-OP EXAM, THE LEFT EYE EXHIBITED A 2-LINE DECREASE IN BCVA AND AN OVERCORRECTION OF 2.5 DIOPTERS. UCVA IMPROVED FROM 20/400 PRE-OP TO 20/80.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LADAR6000 SYSTEM OPHTHALMIC EXCIMER LASER SYSTEM DZS ALCON - ORLANDO TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other