BEUDAMED
    FDA Adverse Event Other Summary report: N

    LENSAR LASER SYSTEM -FS 3D

    MDR report key: 5004133 · Received August 12, 2015

    Report

    Report Number
    3009026057-2015-00024
    Event Type
    Other
    Date Received
    August 12, 2015
    Date of Event
    July 21, 2015
    Report Date
    August 11, 2015
    Manufacturer
    LENSAR INC
    Product Code
    OOE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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

    REVIEW OF THE PROCEDURE FILES SHOWED A WELL CENTERED SUCTION RING AND A TYPICAL PATTERN OF CAPSULOTOMY OCCURRED. BREAKTHROUGH OF THE CAPSULAR INCISION OCCURRED ON SLIDE 7 WHICH IS NORMAL. THE FRAGMENTATION PATTERN APPEARED NORMAL. THERE IS A NOTED GAS BUBBLE THAT APPEARED TO DRIFT POSTERIORLY AT THE 2 O'CLOCK POSITION. IT DOES NOT APPEAR FROM THE IMAGES THAT ANY ISSUE OCCURRED. IT CANNOT BE DETERMINED IF THE GAS BUBBLE, THOUGH TYPICAL CREATED ANY ISSUE IN THE PROCEDURE. THE SCHEIMPFLUG SCANS DO SHOW A DENSE PSC CATARACT ON THIS PT. BASED UPON ALL AVAILABLE INFORMATION, THE SYSTEM IN ALL LIKELIHOOD IS NOT THE CAUSE OF THE POSTERIOR RUPTURE. DURING A POST-OPERATIVE CLINICAL FOLLOW UP, THE DOCTOR STATED THAT THE PATIENT WAS DOING FINE. ROOT CAUSE: UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY HAD A PATIENT WHERE THE DOCTOR THINKS THE LASER HIT THE POSTERIOR CAPSULE. THE DOCTOR DID AN ANTERIOR VITRECTOMY AND SULCUS LENS PLACEMENT ON THE PATIENT DURING THE INITIAL SURGERY. THE DOCTOR FELT THAT THE LENS SEEMED TO BEHAVE WEIRD WHEN HE STARTED SURGERY LEADING TO QUESTIONING IF THE LASER WENT THROUGH THE POSTERIOR CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529472 LENSAR LASER SYSTEM -FS 3D LENSAR LASER SYSTEM -FS 3D OOE LENSAR INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other