BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 14843662 · Received June 28, 2022

    Report

    Report Number
    3009026057-2019-00001
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    January 30, 2019
    Report Date
    March 11, 2019
    Manufacturer
    LENSAR, INC
    Product Code
    OOE
    PMA / PMN Number
    K182795
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2019, A CUSTOMER REPORTED TO LENSAR CAS THAT THEY HAD AN ANTERIOR CAPSULE TEAR ON A PATIENT. NO VITRECTOMY NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939308 LENSAR LASER SYSTEM-FS 3D LENSAR LASER SYSTEM-FS 3D OOE LENSAR, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Unknown Other