BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADAR6000 SYSTEM

    MDR report key: 835934 · Received April 4, 2007

    Report

    Report Number
    1061857-2007-00118
    Event Type
    Injury
    Date Received
    April 4, 2007
    Date of Event
    January 9, 2007
    Report Date
    March 13, 2007
    Manufacturer
    ALCON-ORLANDO TECHNOLOGY CTR
    Product Code
    LZS
    Removal / Correction Number
    1061857-02/21/2007-002-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION, INCLUDING ROOT CAUSE DETERMINATION HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    A DOCTOR OF OPTOMETRY REPORTS 4 PTS WITH TOPOGRAPHICALLY-OBSERVED "CENTRAL ISLANDS" (CORNEAL IRREGULARITIES) FOLLOWING A CUSTOM MYOPIA WITH ASTIGMATISM LASER PROCEDURE. THIS REPORT IS FOR THE THIRD PT, THE OTHER PTS ARE BEING SUBMITTED UNDER THE FOLLOWING MFR NUMBERS: 1061857-2007-00116, 1061857-2007-00117, 1061857-2007-00119. THIS PT RECEIVED A CUSTOM BILATERAL PROCEDURE. THIS REPORT IS FOR THE RIGHT EYE. AT THE 2-MONTH POST-OP EXAM, THIS PT EXHIBITED A TWO LINE DECREASE IN BCVA IN THE RIGHT EYE. THE PT ALSO REPORTED BLURRY VISION, SHADOWING AND DIFFICULTY FOCUSING. ADD'L INFO HAS BEEN REQUESTED. SURFACE IRREGULARITIES ASSOCIATED WITH LASER REFRACTIVE SURGERY CAN INTERFERE WITH VISION. SOME IRREGULARITIES SPONTANEOUSLY RESOLVE AFTER SEVERAL MONTHS. PTS 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 SYSTEM LZS ALCON-ORLANDO TECHNOLOGY CTR NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other GENERIC| IMITREX| ORAL CONTRACEPTIVE