BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5381016 · Received January 20, 2016

    Report

    Report Number
    3009026057-2015-00049
    Event Type
    Injury
    Date Received
    January 20, 2016
    Date of Event
    December 21, 2015
    Report Date
    January 29, 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
    CA, 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

    PATIENT FILES WERE REVIEWED AND THE CAPSULOTOMY APPEARED COMPLETE. THERE WAS NO NOTED EYE MOVEMENT DURING THE SURGICAL PROCEDURE. THE CAPSULOTOMY EDGE DOES FORM ATYPICALLY WITH WHAT IS REFERRED TO AS "SAUSAGE" PATTERN. THIS IS SEEN WITH SUB-OPTIMAL PHOTO DISRUPTION AND COULD CREATE ADHESIONS IN THE CAPSULAR CUT. THE LASER SYSTEM LOG FILES WERE REVIEWED AND THE SURGICAL PROCEDURE WAS COMPLETED 100% WITH NO ERRORS RECORDED. NO EVIDENCE OF DEVICE MALFUNCTION WAS FOUND. THE DOCTOR'S OFFICE WAS CONTACTED BY A LENSAR CAS ASKING FOR THE POST-OPERATIVE CLINICAL PATIENT INFORMATION, BUT THE DOCTOR'S OFFICE DID NOT PROVIDE IT. ROOT CAUSE: UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE EXPERIENCED AN ANTERIOR CHAMBER TEAR AFTER THE LENSAR WAS PERFORMED ON (B)(6) 2015.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE EXPERIENCED AN ANTERIOR CHAMBER TEAR AFTER THE LENSAR WAS PERFORMED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38061 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