BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5519882 · Received March 23, 2016

    Report

    Report Number
    3009026057-2016-00010
    Event Type
    Injury
    Date Received
    March 23, 2016
    Date of Event
    February 22, 2016
    Report Date
    March 22, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE SURGICAL IMAGES SUBMITTED CONFIRMED THAT THE LOCALIZED IMAGING TEST SHOTS WERE A LITTLE BELOW THE TARGET OF 50% CORNEAL THICKNESS, HOWEVER, THE SOFTWARE COULD IDENTIFY THE CENTROID ON ALL FOUR SCANS. THE SOFTWARE WILL OFFSET THE ARCUATE PATTERN APPROPRIATELY BASED ON THE CENTROID IDENTIFIED IN EACH SCAN. MOST LIKELY THE CORNEA WAS PERFORATED DURING THE TITRATION PROCEDURE PERFORMED DURING THE PHACO PROCEDURE. WE WERE UNABLE TO REPRODUCE (B)(6) COMMENTS REGARDING THE PROGRESS BAR BEING BELOW WHERE IT SHOULD HAVE BEEN DURING THE PROCEDURE. NO INDICATION OF DEVICE MALFUNCTION WAS FOUND. DURING A POST-OPERATIVE CLINICAL FOLLOW UP THE DOCTOR REPORTED THAT NO SURGICAL INTERVENTION WAS NEEDED AND THE PATIENT WAS DOING FINE. ROOT CASUSE: DOCTOR RELATED DURING THE PHACO PROCEDURE

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE SURGICAL IMAGES SUBMITTED CONFIRMED THAT THE LOCALIZED IMAGING TEST SHOTS WERE A LITTLE BELOW THE TARGET OF 50% CORNEAL THICKNESS; HOWEVER, THE SOFTWARE COULD IDENTIFY THE CENTROID ON ALL FOUR SCANS. THE SOFTWARE WILL OFFSET THE ARCUATE PATTERN APPROPRIATELY BASED ON THE CENTROID IDENTIFIED IN EACH SCAN. MOST LIKELY THE CORNEA WAS PERFORATED DURING THE TITRATION PROCEDURE PERFORMED DURING THE PHACO PROCEDURE. WE WERE UNABLE TO REPRODUCE DR. (B)(6)'S COMMENTS REGARDING THE PROGRESS BAR BEING BELOW WHERE IT SHOULD HAVE BEEN DURING THE PROCEDURE. NO INDICATION OF DEVICE MALFUNCTION WAS FOUND. DURING A POST-OPERATIVE CLINICAL FOLLOW UP THE DOCTOR REPORTED THAT NO SURGICAL INTERVENTION WAS NEEDED AND THE PATIENT WAS DOING FINE. ROOT CAUSE: DOCTOR RELATED DURING THE PHACO PROCEDURE

    Description of Event or Problem · 1

    DOCTOR INFORMED TO A LENASR FIELD SERVICE REPRESENTATIVE THAT A PATIENT HAD CORNEAL MICRO PERFORATIONS.

    Description of Event or Problem · 1

    DOCTOR INFORMED TO A LENSAR FIELD SERVICE REPRESENTATIVE THAT A PATIENT HAD CORNEAL MICRO PERFORATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177865 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