BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5643294 · Received May 10, 2016

    Report

    Report Number
    3009026057-2016-00014
    Event Type
    Injury
    Date Received
    May 10, 2016
    Date of Event
    March 15, 2016
    Report Date
    May 13, 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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FILES WERE REVIEWED AND OF THE 10 SCANS 7 FOUND ALL SURFACES CORRECTLY. SCANS 3-5 DID NOT PROPERLY IDENTIFY THE POSTERIOR LENS. TWO WERE A RESULT OF A SHADOW FROM THE PATIENT NOSE BLOCKING THE SCAN. THE 3D RECONSTRUCTION WAS REPROCESSED AND THE DATA WAS WITHIN NORMAL EXPECTATIONS. TREATMENT FILES WERE REVIEWED AND THE TREATMENT PROGRESSED NORMALLY WITHOUT ANY NOTED ISSUE. IT CANNOT BE DETERMINED FROM THE TREATMENT FILES IF THE LASER CAUSED ANY ISSUE WITH THE POSTERIOR CAPSULAR TISSUE. NO EVIDENCE OF DEVICE MALFUNCTION WAS FOUND. ROOT CAUSE: UNKNOWN.

    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 APRIL 11, 2016 A DISTRIBUTOR CLINICAL APPLICATION SPECIALIST REPORTED THAT THE SURGEON HAD A CASE ON (B)(6) 2016 THAT HAD TO PERFORM A VITRECTOMY DUE TO THE BAG BEING EXTREMELY FRAGILE.

    Description of Event or Problem · 1

    ON APRIL 11, 2016 A DISTRIBUTOR CLINICAL APPLICATION SPECIALIST REPORTED THAT THE SURGEON HAD A CASE ON (B)(6) 2016 THAT HAD TO PERFORM A VITRECTOMY DUE TO THE BAG BEING EXTREMELY FRAGILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298228 LENSAR LASER SYSTEM-FS 3D LENSAR LASER SYSTEM-FS 3D OOE LENSAR, LLC 70-00013-001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other