BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5438392 · Received February 16, 2016

    Report

    Report Number
    3009026057-2016-00004
    Event Type
    Injury
    Date Received
    February 16, 2016
    Date of Event
    January 18, 2016
    Report Date
    February 26, 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
    MD, 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 AND THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. REVIEW OF THE (B)(6) SCANS SHOWED EITHER VITREOUS COMING AROUND THE LENS INTO THE ANTERIOR CHAMBER OR A RUPTURED POSTERIOR CAPSULE WITH CORTICAL ESCAPE. THIS WAS VISIBLE DURING THE SCANNING PROCESS AND WAS NOT CAUSED BY THE LASER SYSTEM. THIS WAS NOT A LASER RELATED EVENT THERE WAS NO OTHER CLINICAL INTERVENTION REQUIRED. THE DOCTOR ALSO BELIEVED THAT THE LASER SYSTEM DID NOT CONTRIBUTE TO THE ANTERIOR VITRECTOMY EVENT. ROOT CAUSE: PATIENT RELATED EVENT.

    Description of Event or Problem · 1

    DOCTOR REPORTED TO A LENSAR SALES REPRESENTATIVE THAT HE KEEPS HAVING ISSUES WITH THE LASER IMAGING AND IDENTIFICATION. ONE CASE I WITNESSED THE LASER PORTION SEEMED TO GO FINE AND I STEPPED OUT OF THE ROOM DUE TO OTHER REP TRAFFIC. AND ALSO BECAME AWARE THAT DR. (B)(6) WAS PERFORMING AN ANTERIOR VITRECTOMY. HE WASN'T SURE WHERE THE VITREOUS CAME FROM AND I ASKED IF THE PATIENT HAD WEAK ZONULES WHICH HE AGREED MAY BE THE CASE BUT WANTED US TO LOOK AT THE LASER FILES JUST IN CASE.

    Description of Event or Problem · 1

    DOCTOR REPORTED TO A LENSAR SALES REPRESENTATIVE THAT HE KEEPS HAVING ISSUES WITH THE LASER IMAGING AND IDENTIFICATION. ONE CASE I WITNESSED THE LASER PORTION SEEMED TO GO FINE AND I STEPPED OUT OF THE ROOM DUE TO OTHER REP TRAFFIC. AND ALSO BECAME AWARE THAT DR. (B)(6) WAS PERFORMING AN ANTERIOR VITRECTOMY. HE WASN'T SURE WHERE THE VITREOUS CAME FROM AND I ASKED IF THE PATIENT HAD WEAK ZONULES WHICH HE AGREED MAY BE THE CASE BUT WANTED US TO LOOK AT THE LASER FILES JUST IN CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95006 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