BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 14843969 · Received June 28, 2022

    Report

    Report Number
    3009026057-2021-00003
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    March 31, 2021
    Report Date
    April 16, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REVIEWING THE SURGICAL DATA. THE INTENDED AXIS WAS SHIFTED DUE TO THE PATIENT'S HEAD BEING TILTED MORE THAN 25 DEGREES AND THE SURGEON DID NOT USE THE SPUDNIKS TO COMPENSATE FOR THE CYCLOTORSION ONCE THE IRIS REGISTRATION FAILED. IRIS REGISTRATION LIKELY FAILED DUE TO THE PATIENT'S HEAD NOT BEING POSITIONED STRAIGHT. THE LASER OPERATOR IGNORED THE WARNING MESSAGE AND DID NOT MAKE THE SURGEON AWARE. THE LOG FROM THE EVENT INDICATES IRIS REGISTRATION FAILURE (AND FAILURE IN THIS CASE MEANS IRIS REGISTRATION WILL NOT WORK OUTSIDE THE LIMITS OF ROTATION THE SYSTEM IS DESIGNED FOR) DUE TO ROTATION ABOVE THE LIMIT FOR THE DEVICE. THIS RESULTS IN THE ERROR MESSAGE "GREATER THAN 21 DEGREES OF CYCLOROTATION DETECTED. ROTATION ANGLE ADJUSTMENT NOT APPLIED. RELEASE PATIENT. REVERT TO USING INK MARKS TO REALIGN AND REDOCK PATIENT TO THE SYSTEM." THERE WERE NO INK MARKS VISIBLE THAT WOULD INDICATE MANUAL ROTATION OF THE LENS. THE DETECTED AMOUNT OF CYCLOROTATION WAS -26. THE USER IGNORED THE WARNING MESSAGE AND PROCEEDED WITH THE TREATMENT.

    Description of Event or Problem · 0

    DR. (B)(6) FROM CENTER FOR SIGHT REPORTED THAT ON CASE # (B)(6) HE PLANNED INTELLIAXIS L/C AT AXIS 104 BUT INSTEAD DISCOVERED AXIS AT 130 ON PATIENT'S 1-DAY POST OP EXAM. DR. (B)(6) PLACED TORIC LENS AT 130 INSTEAD OF THE INTENDED AXIS OF 104. THE DOCTOR WILL BE PERFORMING ADDITIONAL SURGERY ON THE PATIENT TO ROTATE THE LENS TO THE CORRECT POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813811 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 Unknown Required Intervention