BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 14844009 · Received June 28, 2022

    Report

    Report Number
    3009026057-2021-00004
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    June 24, 2021
    Report Date
    June 30, 2021
    Manufacturer
    LENSAR, INC
    Product Code
    OOE
    PMA / PMN Number
    K182795
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DEMONSTRATED THAT THE SYSTEM PERFORMED AS INTENDED AND THAT THE PERFORATION LIKELY OCCURRED WHEN THE SURGEON OPENED UP THE AK DUE TO HIS TECHNIQUE.

    Description of Event or Problem · 0

    P1008 - NAISSUE: MICHELLE LORZ FROM (B)(4) INSTITUTE - LLS2297 REPORTED TOJANET EISCHENS ON (B)(6) 2021 THAT ON CASE (B)(4) WHEN OPENING TEMPORAL AK, ITPERFORATED, AND A SUTURE WAS NEEDED. SURGEON SEEKING REVIEW AND WANTS TOKNOW IF THIS WAS CAUSED BY THE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044381 LENSAR LASER SYSTEM-FS 3D LENSAR LASER SYSTEM-FS 3D OOE LENSAR, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Prefer Not To Disclose Required Intervention