BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTA II

    MDR report key: 1576542 · Received January 11, 2010

    Report

    Report Number
    2914019-2010-00003
    Event Type
    Injury
    Date Received
    January 11, 2010
    Date of Event
    December 15, 2009
    Report Date
    January 12, 2010
    Manufacturer
    LUMENIS, INC.
    Product Code
    HQF
    PMA / PMN Number
    K004006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL SPECIALIST FOUND THAT THE DEVICE OPERATED WITHIN SPECIFICATION, AND THERE WERE NO RELATED DEVICE MALFUNCTIONS. REASONABLE ATTEMPTS WERE MADE TO CONTACT THE USER FACILITY, HOWEVER, NO ADDITIONAL INFO WAS PROVIDED. SHOULD ADDITIONAL INFO BE REPORTED, A FOLLOW UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PTS SUSTAINED CORNEAL EDEMA AFTER SELECTIVE LASER TRABECULOPLASTY (SLT) TREATMENT WITH A SELECTA II LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTA II ND: YAG SURGICAL LASER HQF LUMENIS, INC. SELECTA II NA

    Patients

    Seq Age Sex Outcome Treatment
    1