BEUDAMED
    FDA Adverse Event Other Summary report: N

    LENSAR LASER SYSTEM -FS 3D

    MDR report key: 3772915 · Received February 26, 2014

    Report

    Report Number
    3009026057-2014-00001
    Event Type
    Other
    Date Received
    February 26, 2014
    Date of Event
    January 30, 2014
    Report Date
    February 24, 2014
    Manufacturer
    LENSAR INC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TPRF CHANGE MESSAGES ARE NORMAL INFORMATIONAL MESSAGES DISPLAYED BY THE SOFTWARE TO INFORM THE SURGEON OF CHANGES APPLIED TO A SPECIFIC PATTERN AS DEFINED BY THE RETINAL SAFETY ALGORITHMS IN THE SOFTWARE. THESE ARE EXPECTED DURING NORMAL USE OF THE SYSTEM AND FUNCTIONED IN THIS CASE AS INTENDED BY DESIGN. ANALYSIS OF THE SCHEIMPFLUG IMAGES OF THIS PATIENT'S ANTERIOR SEGMENT AND CATARACT REVEALED VERY LITTLE PT MOVEMENT IN THE Z AXIS. SIGNIFICANT Z MOVEMENT WOULD HAVE BEEN AN INDICATOR OF A POOR INTERFACE LOCK AND RESULTANT Z MOVEMENT DURING THE LASER PORTION OF THE PROCEDURE. ANALYSIS OF SYSTEM "DOWN THE PIE" IMAGES CAPTURED DURING PHOTODISRUPTION LIKEWISE REVEALED VERY LITTLE SIDE TO SIDE MOVEMENT. THE CAPSULOTOMY IS COMPLETED WITHOUT INCIDENT. THE LASER DELIVERED WITHIN THE CONFINES OF THE ANTERIOR AND POSTERIOR CAPSULES AND NOT ACROSS THE POSTERIOR CAPSULE OR IN THE VITREOUS CHAMBER. THERE IS NO DATA BASED ON THE FAILURE INVESTIGATION TO EVIDENCE LASER PULSES DIRECTED AT THE POSTERIOR CAPSULE OR VITREOUS BODY. SUCTION LOSS OCCURRED IN THIS CASE TOWARDS THE VERY END OF THE LENS FRAGMENTATION (TOTAL PROCEDURE 98%). IT IS HIGHLY UNLIKELY THAT THE LASER SYSTEM DELIVERED ANY LASER PULSES ON THE POSTERIOR CAPSULE IN THIS CASE. POSTERIOR CAPSULE RUPTURE MAY POTENTIALLY HAVE OCCURRED DUE TO MECHANICAL FORCE PROPAGATION WITHIN THE LENS CAPSULE DURING PHACOEMULSIFICATION AND NUCLEOFRACTIS. BASED ON THE ANALYZED INFO NO ROOT CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO A LENSAR FSE ON (B)(6) 2013 THAT THEY RECEIVED A "PRF CHANGE" MESSAGE DISPLAYED DURING SURGERY FOLLOWED BY THE LASER NOT FIRING, DESPITE THE DOCTOR STILL HOLDING THE FIRE BUTTON. THE "RUN" BUTTON BECAME ACTIVE SHORTLY AFTER THE LASER STOPPED FIRING AND THE TECHNICIAN PRESSED IT AGAIN AND THE DOCTOR CONTINUED WITH THE PROCEDURE UNTIL A "LOSS OF SUCTION" ERROR OCCURRED AND THE CASE WAS ABORTED. THE DOCTOR NOTED DURING THE PHACO PROCEDURE THAT THE FIRST CHOP HAD FIRED THROUGH THE POSTERIOR OF THE LENS AND THE DOCTOR HAD TO PERFORM A LENS VITRECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119347 LENSAR LASER SYSTEM -FS 3D LENSAR LASER SYSTEM -FS 3D OOE LENSAR INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK