BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION 4000

    MDR report key: 705005 · Received March 27, 2006

    Report

    Report Number
    1061857-2006-00158
    Event Type
    Injury
    Date Received
    March 27, 2006
    Report Date
    September 27, 2005
    Manufacturer
    ALCON - ORLANDO TECHNOLOGY CENTER
    Product Code
    DZS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING LASIK SURGERY, THIS PATIENT EXHIBITED AN INCREASE IN MRSE OF 3.75 DIOPTERS IN THE RIGHT EYE AT THE 3-MONTH POST-OPERATIVE EXAM. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other