BEUDAMED
    FDA Adverse Event Other Summary report: N

    LENSAR LASER SYSTEM -FS 3D

    MDR report key: 3593370 · Received January 7, 2014

    Report

    Report Number
    3009026057-2013-00019
    Event Type
    Other
    Date Received
    January 7, 2014
    Date of Event
    December 9, 2013
    Report Date
    January 7, 2014
    Manufacturer
    LENSAR INC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    JUST BEFORE THE SURGERY, THE LASER SHOWED THE RED RING FOR THE CAPSULOTOMY OVER THE IRIS. THE DR NOTICED THE DECENTRATION OF THE TREATMENT AND ALSO NOTICED THE LASER PLACED SHOTS INTO THE PT IRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11570 LENSAR LASER SYSTEM -FS 3D LENSAR LASER SYSTEM -FS 3D OOE LENSAR INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other