BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 14521867 · Received May 27, 2022

    Report

    Report Number
    3009026057-2022-00017
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    April 28, 2022
    Report Date
    May 26, 2022
    Manufacturer
    LENSAR, INC
    Product Code
    OOE
    UDI-DI
    0086774400112
    PMA / PMN Number
    K182795
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CENTRATION WAS SUPERIOR WITH MOVEMENT NOTED THROUGHOUT TREATMENT. SUCTION RING APPLANATION WAS POOR WITH AN AIR BUBBLE LOCATED AT 305-DEGREES. SOFTWARE PLACED LENS DENSITY AS A CATEGORY 3 PATTERN. CAPSULOTOMY TREATMENT BEGINS AT FRAME #3 WITH A 30-DEGREE EXPANSION IN NASAL AREA AT FRAME #4. THIS EXPANSION CUT MAY HAVE BEEN A COMBINATION CAUSED BY THE PRESSURE WITHIN THE LENS BAG AND PATIENT MOVEMENT. FRAGMENTATION TREATMENT STARTS AT FRAME #11 WITH CONTINUED MOVEMENT OF THE EYE. SYSTEM SAFETY INTERLOCK DETECTED ERROR INITIATED AND PROCEDURE WAS STOPPED AT 70%. AK TREATMENT WAS SKIPPED AND PERFORMED ON SECOND PROCEDURE. THE LASER FUNCTIONED AS DESIGNED. PATIENT MOVEMENT AND IMPROPER SUCTION CUP RING APPLANATION OF THE EYE.

    Description of Event or Problem · 0

    P1008 - ANTERIOR RADIAL TEAR - ISSUE: ON (B)(6) 2022 WHILE ON SITE ((B)(4)) (B)(6) STATED THAT DR. (B)(6) CHOSE TO COMPLETE AKS PLANNED (CASE#(B)(4)). WHILE IN THE OR, DR. (B)(6) NOTED AN ANTERIOR CAPSULAR TEAR. PLANNEDIOL WAS IMPLANTED WITHOUT VITRECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2763106 LENSAR LASER SYSTEM-FS 3D LENSAR LASER SYSTEM-FS 3D OOE LENSAR, INC N/A N/A 0086774400112

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other