BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION 4000 LASER

    MDR report key: 1407147 · Received June 24, 2009

    Report

    Report Number
    1061857-2009-00035
    Event Type
    Injury
    Date Received
    June 24, 2009
    Date of Event
    December 4, 2008
    Report Date
    May 25, 2009
    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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SURGERY DATABASE PERFORMANCE VERIFICATION WAS PERFORMED ON THIS LASER SYSTEM. THE ANALYSIS DETERMINED THE LASER PERFORMANCE FACTORS ANALYZED WERE OPERATING WITHIN SPECIFICATION DURING THE TIME OF THE PATIENT'S SURGERY. DURING THE ON-SITE INVESTIGATION, THE ENGINEER WAS UNABLE TO FIND ANY ISSUES WITH THE LASER AND COMPLETED A SUCCESSFUL SYSTEM VERIFICATION TO SPECIFICATIONS.

    Description of Event or Problem · 1

    A SURGEON REPORTS DISSATISFACTION WITH PATIENT OUTCOMES. ADDITIONAL INFORMATION PROVIDED BY THE SURGEON INDICATES THIS PATIENT RECEIVED A BILATERAL CUSTOM LASIK TREATMENT. THIS REPORT IS FOR THE RIGHT EYE, THE LEFT EYE IS BEING REPORTED UNDER MANUFACTURER REPORT # 161857-2009-00036. POSTOPERATIVELY, THIS PATIENT EXHIBITED A SMALL UNDERCORRECTION (-.05 DIOPTER) IN THE RIGHT EYE. IT IS UNKNOWN IF THE SURGEON FEELS THIS PATIENT IS HARMED / INJURED. ADDITIONAL INFORMATION PROVIDED FROM THE SURGEON INDICATES THE PATIENT IS HAPPY, BUT SQUINTS A LITTLE. SURGEON MAY ENHANCE THE PATIENT LATER IN THE YEAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other