BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5462957 · Received February 26, 2016

    Report

    Report Number
    3009026057-2016-00005
    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
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TREATMENT FILES WERE REVIEWED AND THE CAPSULOTOMY PROCEEDED NORMALLY. FRAME 3 SHOWED THE BEGINNING OF THE CAPSULAR CUT AND ON FRAME 6 THERE WAS THE FIRST BREAKTHROUGH WITH FULL BREAKTHROUGH ON THE NEXT FRAME. THERE WAS NO INDICATION OF ANY UNCUT AREAS. THIS SYSTEM IS CURRENTLY SET TO NON-DEFAULT PARAMETERS. LASER LOG FILES WERE REVIEWED AND THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION. THE SURGICAL PROCEDURE COMPLETED 100% AND NO ERROR MESSAGES WERE RECORDED. NO MEDICAL INTERVENTION WAS PERFORMED AND THE DOCTOR HAS NO POST-OPERATIVE SURGICAL PROCEDURE CONCERNS. 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 CUSTOMER REPORTED THAT DURING SURGICAL PROCEDURE HAD AN INCOMPLETE CAPSULOTOMY WHICH LED TO CAPSULAR TEAR. NO VITRECTOMY WAS PERFORMED AND NO POST OPERATIVE CONCERNS.

    Description of Event or Problem · 1

    ON (B)(6) 2016 CUSTOMER REPORTED THAT DURING SURGICAL PROCEDURE HAD AN INCOMPLETE CAPSULOTOMY WHICH LED TO CAPSULAR TEAR. NO VITRECTOMY WAS PERFORMED AND NO POST OPERATIVE CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120226 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