BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5666007 · Received May 19, 2016

    Report

    Report Number
    3009026057-2016-00015
    Event Type
    Injury
    Date Received
    May 19, 2016
    Date of Event
    April 22, 2016
    Report Date
    June 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN ANALYSIS OF THE IMAGES, IT DOES NOT APPEAR THAT THE LASER IMPACTED THE POSTERIOR CAPSULE. THE SCHEIMPFLUG IMAGES WERE REVIEWED AND IN ALL 10 IMAGES ALL SURFACES WERE PROPERLY IDENTIFIED. THE DEFAULT POSTERIOR CAPSULE CLEARANCE WAS USED (1MM). THERE WAS LITTLE TO NO EYE MOVEMENT NOTED DURING THE PROCEDURE. LASER LOG FILES WERE REVIEWED AND THE SURGICAL PROCEDURE WAS COMPLETED 100% WITH NO ERROR MESSAGES RECORDED. NO DEVICE FAILURE WAS FOUND. A VITRECTOMY WAS PERFORMED. DURING A POST- OPERATIVE CLINICAL FOLLOW UP THE DOCTOR REPORTED THAT, THAT PATIENT HAS A VISUAL ACUITY OF 20/25 AND NO OTHER ISSUES OR CONCERNS HAS BEEN REPORTED. ROOT CAUSE: UNKNOWN.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, DOCTOR REPORTED A POSTERIOR TEAR AND A VITRECTOMY WAS PERFORMED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, DOCTOR REPORTED A POSTERIOR TEAR AND A VITRECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321577 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