BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5463322 · Received February 26, 2016

    Report

    Report Number
    3009026057-2016-00006
    Event Type
    Injury
    Date Received
    February 26, 2016
    Date of Event
    January 27, 2016
    Report Date
    March 1, 2016
    Manufacturer
    LENSAR, LLC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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

    TREATMENT FILE WAS REVIEWED AND SHOWED A SUBOPTIMAL SUCTION QUALITY FROM ONSET. NO SPECKLE PATTERN WAS VISIBLE ON THE INNER RING FROM THE BEGINNING. ON FRAME 43 A FULL SUCTION LOSS OCCURS. ONE ADDITIONAL FRAME CAPTURED AND IN REVIEW IT IS DIFFICULT TO CONFIRM CORNEAL ETCH. LASER SYSTEM LOG FILES WERE REVIEWED AND THERE WAS NO INDICATION OF DEVICE MALFUNCTION. DURING A POST-OPERATIVE CLINICAL FOLLOW UP THE DOCTOR REPORTED TO A LENSAR CLINICAL APPLICATION SPECIALIST THAT THERE WERE NO COMPLICATIONS OR INTERVENTION NEEDED AND THE PATIENT POST OP WAS DOING FINE. ROOT CAUSE: IMPROPER DOCKING AND LOCKING OF PID.

    Description of Event or Problem · 1

    ON 1/27/16 A LENSAR CAS REPORTED THAT DURING A SURGICAL PROCEDURE A WATER LOSS IN THE PID OCCURRED FOLLOWING A TARGET/WATER LOSS INDICATOR AND VACUUM LEAK ABORT, AND THE CORNEA WAS LIGHTLY MARKED. NO SURGICAL COMPLICATIONS WERE REPORTED AND NO CLINICAL INTERVENTION WAS NEEDED. DURING A POST-OPERATIVE CLINICAL FOLLOW UP THE DOCTOR REPORTED TO A LENSAR CAS THAT THE PATIENT WAS DOING FINE

    Description of Event or Problem · 1

    ON(B)(6) 2016 A LENSAR CAS REPORTED THAT DURING A SURGICAL PROCEDURE A WATER LOSS IN THE PID OCCURRED FOLLOWING A TARGET/WATER LOSS INDICATOR AND VACUUM LEAK ABORT, AND THE CORNEA WAS LIGHTLY MARKED. NO SURGICAL COMPLICATIONS WERE REPORTED AND NO CLINICAL INTERVENTION WAS NEEDED. DURING A POST-OPERATIVE CLINICAL FOLLOW UP THE DOCTOR REPORTED TO A LENSAR CAS THAT THE PATIENT WAS DOING FINE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119448 LENSAR LASER SYSTEM-FS 3D LENSAR LASER SYSTEM-FS 3D OOE LENSAR, LLC 70-00005-001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other