BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 14843944 · Received June 28, 2022

    Report

    Report Number
    3009026057-2021-00001
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    February 1, 2021
    Report Date
    February 19, 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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REVIEWING THE SURGICAL IMAGES, IT WAS NOTED THAT THERE WAS SIGNIFICANT EYE MOVEMENT DURING THE CASE CAUSING THE AK INCISION FULL THICKNESS. NOTE THAT THE PID MOVED RELATIVE TO THE TITANIUM ARM AND SOME MOVEMENT IN THE TITANIUM ARM. THE MOVEMENT WAS SEEN IN FRAMES 39 AND 40, SPECIFICALLY AT THE DELTA IN EYE POSITION. LATERAL MOVEMENT WILL RESULT IN Z ERROR WHEN THE LASER FIRES ON A CURVED SURFACE LIKE THE CORNEA. THE DOCTOR REPORTED THAT THE PATIENT WAS DOING FINE AND WOULD PROBABLY LEAVE THE SUTURES IN FOR AT LEAST A MONTH OR SO, BUT THE PATIENT WILL DO FINE.

    Description of Event or Problem · 0

    ON (B)(6) 2021, WHILE FSE WAS ONSITE, THE DOCTOR REPORTED THAT UPON OPENING THE TEMPORAL AK OF A PATIENT, HE NOTICED FLUID COMING FORWARD. THE DOCTOR STATED THAT THE TEMPORAL AK WAS COMPLETE FULL-THICKNESS ACROSS THE FULL AK. HE STATED THAT THE NASAL AK WAS OPEN WITH NO ISSUES. SURGICAL INTERVENTION WAS REQUIRED. TTHE INCISION WAS SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939318 LENSAR LASER SYSTEM-FS 3D LENSAR LASER SYSTEM-FS 3D OOE LENSAR, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Other