BEUDAMED
    FDA Adverse Event Other Summary report: N

    LENSAR LASER SYSTEM -FS 3D

    MDR report key: 5004135 · Received August 12, 2015

    Report

    Report Number
    3009026057-2015-00026
    Event Type
    Other
    Date Received
    August 12, 2015
    Date of Event
    July 22, 2015
    Report Date
    August 11, 2015
    Manufacturer
    LENSAR INC
    Product Code
    HQC
    PMA / PMN Number
    K120214
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE LASER SYSTEM LOG FILES WERE REVIEWED AND CONFIRMED THAT THERE WAS A VACUUM LEAK DETECTED FOLLOWING BY A LOSS OF SUCTION. NO OTHER ISSUES WERE RECORDED IN THE LASER SYSTEM LOG FILES. THE SURGICAL IMAGES WERE REVIEWED AND NOTED THAT THE SUCTION RING WAS CENTERED. THE PROCEDURE PROGRESSED UNTIL FRAME 42 WHERE A FULL LOSS OF SPECKLE PATTERN IN THE SUCTION RING WAS SEEN AND THEN ON THE NEXT FRAME A FULL SUCTION LOSS OCCURRED. DURING A POST-OPERATIVE CLINICAL FOLLOW UP, THE DOCTOR STATED THE PATIENT'S VISION WAS 20/20 AND HIS REFRACTION WAS +.50 SPH 20/20. ROOT CAUSE: UNKNOWN AS TO WHY THERE WAS A VACUUM LEAK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO A LENSAR CLINICAL APPLICATION SPECIALIST THAT THE DOCTOR HAD A PT WHO LOST SUCTION AND THE LASER ETCHED THE CORNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530095 LENSAR LASER SYSTEM -FS 3D LENSAR LASER SYSTEM -FS 3D HQC LENSAR INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other