BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 10831404 · Received November 12, 2020

    Report

    Report Number
    3009026057-2020-00002
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    October 20, 2020
    Report Date
    November 2, 2020
    Manufacturer
    LENSAR, INC
    Product Code
    OOE
    PMA / PMN Number
    K182795
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGERY IMAGES AND DATA WERE REVIEWED, AND IT WAS CONFIRMED THAT ONE OF THE ARCUATE INCISIONS PERFORMED DID FULLY PENETRATE THE POSTERIOR CORNEA. FURTHER REVIEW OF THE SCANS' DATA AND POST-PROCESSING SHOWED A MISCALCULATION IN THE CORNEAL THICKNESS THAT REDUCED THE RESIDUAL STROMA BELOW THE 56 UM INTENDED THICKNESS. AN OUTLIER IMAGE WILL BE REMOVED WHEN PROCESSING THE SCHEIMPFLUG SCANS BUT WILL NOT BE CONSIDERED WHEN PERFORMING THE LOCALIZED IMAGING. THE IMAGE IN QUESTION WOULD NOT HAVE IMPACTED THE CORNEAL THICKNESS CALCULATION SINCE THAT IS DONE AFTER THE LOCALIZED IMAGING HAS BEEN PERFORMED. THE DOCTOR WOULD HAVE SEEN AN IMAGE SHOWING THE ERROR IN THE PLACEMENT OF THE POSTERIOR SURFACE ON THE MONITORS WHEN REVIEWING THE PROCEDURE. THE IMAGE WOULD HAVE SHOWN THE POSTERIOR CORNEAL SURFACE WAS MISIDENTIFIED AS BEING LOWER THAN IT WAS.

    Description of Event or Problem · 1

    ON 10/21/2020, A DOCTOR REPORTED THAT ONE AI WAS "FULL THICKNESS, FULL CORD". SHE WAS UNDER THE IMPRESSION THAT ANY "OUTLIER" IMAGES WERE AUTOMATICALLY REMOVED AND NOT USED BUT THAT IS NOT THE CASE WITH THIS PATIENT. SHE ENDED UP PLACING TWO SUTURES IN THE AI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296433 LENSAR LASER SYSTEM-FS 3D LENSAR LASER SYSTEM-FS 3D OOE LENSAR, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other