BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELECTA DUET

    MDR report key: 806746 · Received January 9, 2007

    Report

    Report Number
    2914019-2005-00093
    Event Type
    Other
    Date Received
    January 9, 2007
    Report Date
    January 9, 2007
    Manufacturer
    ELLEX
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE END-USER NOR THE MODEL AND SERIAL OF THE SYSTEM COULD BE CONFIRMED, AND NO FURTHER INVESTIGATION OF THE INCIDENT OR ROOT CAUSE WAS POSSIBLE. IF LUMENIS OBTAINS SIGNIFICANT ADDITIONAL DETAILS, A FOLLOW-UP MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THIS INCIDENT WAS REPORTED TO LUMENIS BY A PHYSICIAN WHO WAS NOT CONNECTED WITH THE USER FACILITY. PER THE INITIAL REPORTER, A SELECTA DUET DEVICE WAS USED IN THE YAG MODE TO TREAT A SECONDARY CATARACT AND AFTER THE PROCEDURE, THE PATIENT DEVELOPED A MACULAR HOLE. THE PATIENT ALLEGES THAT THE MACULAR HOLE WAS CAUSED BY THE CATARACT LASER TREATMENT. BASED ON THE LIMITED DETAILS AVAILABLE, LUMENIS BELIEVES THAT THIS INCIDENT OCCURRED IN 2005, AT A FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTA DUET SELECTA GEX ELLEX UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other NONE REPORTED