BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LADAR6000

    MDR report key: 835148 · Received March 22, 2007

    Report

    Report Number
    1061857-2007-00111
    Event Type
    Malfunction
    Date Received
    March 22, 2007
    Date of Event
    December 8, 2006
    Report Date
    March 5, 2007
    Manufacturer
    ALCON - ORLANDO TECHNOLOGY CENTER
    Product Code
    LZS
    Removal / Correction Number
    1061857-02/21/2007-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS.

    Description of Event or Problem · 1

    A NURSE REPORTS ONE CUSTOM PATIENT WITH TOPOGRAPHICALLY-OBSERVED "CENTRAL ISLANDS" (CORNEAL IRREGULARITIES) FOLLOWING A BILATERAL CUSTOM MYOPIA WITH ASTIGMATISM LASER PROCEDURE. THERE WAS NO PATIENT INJURY/IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. RIGHT EYE: 1061857-2007-00110 MALFUNCTION, LEFT EYE: 1061857-2007-00111 MALFUNCTION. SURFACE IRREGULARITIES ASSOCIATED WITH LASER REFRACTIVE SURGERY CAN INTERFERE WITH VISION. SOME IRREGULARITIES SPONTANEOUSLY RESOLVE AFTER SEVERAL MONTHS. PATIENTS WITH PERSISTING IRREGULARITIES MAY BE TREATED WITH ALTERNATIVE METHODS INCLUDING SPECTACLE CORRECTION, CONTACT LENS CORRECTION OR SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA