BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION EXCIMER LASER SYSTEM

    MDR report key: 411420 · Received August 16, 2002

    Report

    Report Number
    1061857-2002-00004
    Event Type
    Injury
    Date Received
    August 16, 2002
    Date of Event
    July 17, 2002
    Report Date
    July 17, 2002
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LZS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT, SCHEDULED FOR A BILATERAL LASIK PROCEDURE, HAD THE RIGHT EYE TREATED WITH ANOTHER PT'S TREATMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM CUSTOMER NOTED PATIENT HAD ADDITIONAL SUGERY IN 08/2002; ARTISAN LENS IMPLANTED OD. POSTOP BCVA DECREASED TO 3.0. SURGEON PLANS ADDITIONAL PROCEDURE AFTER SUTURES HAVE BEEN REMOVED AND EYE IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LADARVISION EXCIMER LASER SYSTEM EXCIMER LASER SYSTEM LZS ALCON LABORATORIES, INC. LADARVISION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other