BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5401473 · Received February 1, 2016

    Report

    Report Number
    3009026057-2016-00002
    Event Type
    Injury
    Date Received
    February 1, 2016
    Date of Event
    January 5, 2016
    Report Date
    February 11, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL TAGS WERE REMOVED BY THE DOCTOR WITH NO ISSUES REPORTED. NO PATIENT INJURIES WERE REPORTED. NO PROCEDURE FILES WERE SUBMITTED FOR REVIEW. LENSAR CAS SUPPORTED CASES ON SITE ON (B)(6) 2016 AND OPTIMIZED THE CAPSULOTOMY PARAMETERS SETTING TO ADDRESS THESE ISSUES. ALL PROCEDURES THAT DAY WERE COMPLETED WITHOUT INCIDENT. ROOT CAUSE: SURGICAL PARAMETERS NOT OPTIMIZED.

    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

    DOCTOR REPORTED THAT DURING HER LAST FEW SURGERY DAYS DURING THE MONTH OF (B)(6) SHE FEELS THE SECOND PASS IS OVERLAPPING IN A MISALIGNED WAY. SHE STATES THAT SHE IS RECEIVING ANTERIOR CAPSUL TAGS IN THE PRO TEMPORAL AREA. SHE SAID THIS MISALIGNMENT IS PRESENT ON EVERY SINGLE CASE. IN ONE CASE, SHE STATED THE LENS ALMOST TORE.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT DURING HER LAST FEW SURGERY DAYS DURING THE MONTH OF DECEMBER SHE FEELS THE SECOND PASS IS OVERLAPPING IN A MISALIGNED WAY. SHE STATES THAT SHE IS RECEIVING ANTERIOR CAPSUL TAGS IN THE PRO TEMPORAL AREA. SHE SAID THIS MISALIGNMENT IS PRESENT ON EVERY SINGLE CASE. IN ONE CASE, SHE STATED THE LENS ALMOST TORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60165 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