BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5383474 · Received January 21, 2016

    Report

    Report Number
    3009026057-2015-00050
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    December 3, 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
    OK, 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

    LASER SYSTEM LOG FILES WERE REVIEWED FOR PROCEDURE 5721. THE SURGICAL PROCEDURE WAS COMPLETED 100% AND NO ERROR MESSAGES WERE RECORDED. THERE WAS NO INDICATION OF DEVICE MALFUNCTION. THE LENSAR CAS (B)(6) MADE SEVERAL ATTEMPTS TO OBTAIN THE PATIENT'S SURGICAL IMAGES TO PERFORM THE FAILURE INVESTIGATION IN ORDER TO DETERMINE THE POSSIBLE ROOT CAUSE FOR THE EVENT, BUT THE DOCTOR'S OFFICE DID NOT PROVIDE THE REQUESTED INFORMATION. IN ADDITION, THE DOCTOR'S OFFICE DID NOT PROVIDE THE POST-OPERATIVE EVALUATION RESULTS. THEREFORE, WE CAN'T DETERMINE THE ROOT CAUSE FOR THE EVENT.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT THE ARCUATE INCISION WENT ALL THE WAY THROUGH THE CORNEA.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT THE ARCUATE INCISION WENT ALL THE WAY THROUGH THE CORNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41287 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