BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LADAR6000 SYSTEM

    MDR report key: 920379 · Received September 28, 2007

    Report

    Report Number
    1061857-2007-00488
    Event Type
    Malfunction
    Date Received
    September 28, 2007
    Date of Event
    December 7, 2006
    Report Date
    September 10, 2007
    Manufacturer
    ALCON - ORLANDO TECHNOLOGY CENTER
    Product Code
    LZS
    PMA / PMN Number
    P970043
    Removal / Correction Number
    1061857-02/21/2007-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION, INCLUDING ROOT CAUSE DETERMINATION IS IN PROGRESS. THIS REPORT MAILED IN TO FDA ON: 9/28/2007.

    Description of Event or Problem · 1

    A DR OF OPTOMETRY REPORTS, A PT WITH TOPOGRAPHICALLY-OBSERVED "CENTRAL ISLANDS" (CORNEAL IRREGULARITIES) FOLLOWING A CUSTOM MYOPIA WITH ASTIGMATISM LASER PROCEDURE. THIS REPORT IS FOR THE LEFT EYE, THE RIGHT EYE IS BEING SUBMITTED UNDER MFR REPORT NUMBER 1061857-2007-00487. PATIENT RECORDS DO NOT INDICATE AN INJURY FOR THE LEFT EYE. AT 8 MONTHS POST-OP, BCVA IN THE LEFT EYE WAS EQUAL TO THE PRE-OP MEASUREMENT AND UCVA HAD IMPROVED FROM 20/CFF TO 20/30+1. SURFACE IRREGULARITIES ASSOCIATED WITH LASER REFRACTIVE SURGERY CAN INTERFERENCE 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 SYSTEM OPHTHALMIC EXCIMER LASER S YSTEM LZS ALCON - ORLANDO TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR