BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 6142631 · Received December 2, 2016

    Report

    Report Number
    3009026057-2016-00019
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    October 20, 2016
    Report Date
    December 8, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LENSAR CAS WAS ON SITE TO SUPPORT CASES. DURING REVIEW, IT APPEARS SOME MICRO BUBBLES INTERFERED WITH THE LOCALIZED IMAGING AND ALTERED THE ARCUATE DEPTH PLACEMENT. THE SURGICAL IMAGES SHOW A BUBBLE THAT ENTERED THE ANTERIOR CHAMBER UPON ARCUATE CREATION. WHEN THE SURGEON OPENED THE ARCUATE MANUALLY, IT WAS FOUND THE ARCUATE WAS FULL THICKNESS. THE FILES WERE REVIEWED WITH THE SURGEON.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A USER TALKED WITH A LENSAR CAS CONCERNING LASER SETTINGS/PARAMETERS. USER STATED THAT IN THE LAST TWO WEEKS, THEY HAVE HAD CORNEAL PERFORATIONS USING THE ARCUATE INCISIONS (SHE THINKS TWO CASES). SHE SAID THE PERFORATION HAPPENED DURING THE PHACO PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A USER TALKED WITH A LENSAR CAS CONCERNING LASER SETTINGS/PARAMETERS. USER STATED THAT IN THE LAST TWO WEEKS THEY HAVE HAD CORNEAL PERFORATIONS USING THE ARCUATE INCISIONS (SHE THINKS TWO CASES). SHE SAID THE PERFORATION HAPPENED DURING THE PHACO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791181 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