BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5495383 · Received March 11, 2016

    Report

    Report Number
    3009026057-2016-00007
    Event Type
    Injury
    Date Received
    March 11, 2016
    Date of Event
    February 3, 2016
    Report Date
    March 17, 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
    AU
    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

    IN REVIEW OF THE TREATMENT FILES FOR THIS PATIENT, THE ARCUATE INCISIONS LOOKED LIKE THEY PERFORATED INTO THE ANTERIOR CHAMBER. FROM WHAT CAN BE SEEN THE LASER DID NOT START ITS INCISION IN THE ANTERIOR CAPSULE BUT RATHER THE GAS CREATED BY THE FEMTO INCISION VENTED POSTERIORLY. IF THE LASER WOULD HAVE STARTED THE INCISION IN AQUEOUS FLUID, THERE WOULD HAVE BEEN BUBBLES IN THE FLUID PRIOR TO CORNEAL MARKING. WHAT IS SEEN IS A CORNEAL MARK FOLLOWED BY BUBBLES VENTING INTO THE ANTERIOR CAPSULE. THIS OCCURED ON BOTH EYES OF THE PATIENT AND MOST LIKELY WAS A RESULT OF SOME ANATOMICAL ANOMALY WITH THIS PATIENT. BOTH TREATMENTS WERE REVIEWED AND THE SCHEIMPFLUG SCANS SHOWED RECOGNITION OF THE POSTERIOR CORNEAL SURFACE ON ALL OF THE SCANS. NO EVIDENCE OF DEVICE MALFUNCTION WAS FOUND. DURING A POST-OPERATIVE CLINICAL FOLLOW UP, THE DOCTOR REPORTED TO THE DISTRIBUTOR (B)(6) THAT HE DID NOT OPEN THE ARCUATE INCISIONS AND THE PATIENT WAS DOING FINE. ROOT CAUSE: PATIENT ANATOMY.

    Description of Event or Problem · 1

    A DISTRIBUTOR CASE REPORTED THE LASER MADE A MARK ON THE IRIS AREA.

    Description of Event or Problem · 1

    A DISTRIBUTOR (B)(6) REPORTED THE LASER MADE A MARK ON THE IRIS AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151852 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