BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5507955 · Received March 17, 2016

    Report

    Report Number
    3009026057-2016-00009
    Event Type
    Injury
    Date Received
    March 17, 2016
    Date of Event
    February 16, 2016
    Report Date
    March 24, 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
    TN, US
    Reporter Occupation
    NURSE

    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

    THE SYSTEM DEFAULTED TO THE LAST USED RADIUS FOR THE ARCUATE INCISIONS. THE PREVIOUS CASES WERE MOST LIKELY AN INTRASTROMAL MARK FOR TORIC ALIGNMENT. WHEN THESE TWO PROCEDURES WERE PROGRAMED THE SYSTEM OPERATOR DID NOT ADJUST THE RADIUS TO THE INTENDED RADIUS. THE SURGEON ALSO MISSED THIS IN REVIEW OF THE TREATMENT. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. THE DOCTOR'S OFFICE WAS CONTACTED REQUESTING THE PATIENT POST-OPERATIVE CLINICAL RESULTS, BUT THE DOCTOR'S OFFICE DID NOT PROVIDE THE REQUESTED INFORMATION. ON (B)(6) 2016 THE DOCTOR'S OFFICE PROVIDED THE POST-OPERATIVE PATIENT'S CLINICAL FOLLOW UP INFORMATION AND REPORTED THAT NO MEDICAL INTERVENTION WAS REQUIRED, THE PATIENTS WERE DOING FINE AND NO FURTHER FOLLOW UP IS REQUIRED. LENSAR CASE DISCUSSED THE PARAMETER SETTINGS WITH THE DOCTOR. NO OTHER ISSUES HAS BEEN REPORTED. ROOT CAUSE: USER ERROR .

    Description of Event or Problem · 1

    DOCTOR REPORTED HE PLACED ARCUATE INCISIONS ON 2 CONSECUTIVE PATIENTS AT THE INCORRECT OZ. THE INTENDED OZ WAS 8MM, HOWEVER THE 2 PROCEDURES WERE PROGRAMMED AT 6MM.

    Description of Event or Problem · 1

    DOCTOR REPORTED HE PLACED ARCUATE INCISIONS ON 2 CONSECUTIVE PATIENTS AT THE INCORRECT OZ. THE INTENDED OZ WAS 8MM, HOWEVER THE 2 PROCEDURES WERE PROGRAMMED AT 6MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165064 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