BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 14218570 · Received April 27, 2022

    Report

    Report Number
    3009026057-2022-00013
    Event Type
    Injury
    Date Received
    April 27, 2022
    Date of Event
    March 29, 2022
    Report Date
    April 19, 2022
    Manufacturer
    LENSAR, INC
    Product Code
    OOE
    UDI-DI
    10867744000119
    PMA / PMN Number
    K182795
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEASURE: THIS ISSUE ONLY IMPACTED THIS SPECIFIC DEVICE. ANALYZE: (B)(6) REVIEWED THE OPEN CALL FOR (B)(4): CASE #: (B)(4) - CENTRATION OF THE EYE CUP WAS PLACED SUPERIOR. SIGNIFICANT EYE MOVEMENT IS NOTED THROUGHOUT TREATMENT. CAPSULOTOMY BEGINS AT FRAME #3. AT FRAME #5, CAP BREAKTHROUGHS IN NASAL AREA IS DUE TO HEAD TILT. CAP COMPLETION IS NOTED AT FRAME #6. FRAGMENTATION TREATMENT STARTS AT FRAME #11 WITH CONTINUED MOVEMENT OF THE EYE. TWO-PLANE CHOP PATTERN EXTENDING OUT TO 2.59MM WITH A SINGLE CYLINDER CUT OUT TO 2MM IS NOTED AT FRAME #13. LARGE BUBBLES ARE NOTED THROUGHOUT FRAG TREATMENT MOVING ANTERIOR. FRAGMENTATION IS COMPLETED AT FRAME #27. FIRST AK IS STARTED AT FRAME #30 AND SECOND AK IS STARTED AT FRAME #42. ALL TREATMENT IS COMPLETED AT FRAME #53. ROOT CAUSE: PATIENT MOVEMENT AND IMPROPER LOCKING OF THE PID ARM TO THE EYE CUP. ADDITIONALLY, SURGEON TECHNIQUE DURING HYDRODISCECTION AND PHACO REMOVAL MAY HAVE CONTRIBUTED TO CAPSULE TEAR DURING SURGICAL TREATMENT. LASER FUNCTIONED AS DESIGNED IMPROVE/INNOVATE/CONTROL: DR (B)(4) STATED THAT SHE REMOVED THE CAP BUTTON EASILY BUT FELT DURING GENTLE HYDRODISECTION SHE DIDN'T GET ANY REAL BUBBLE RELEASE. SHE ROCKED THE LENS GENTLY AND ROTATED IT FREELY WITH NOT A LOT OF BUBBLES COMING UP. AS SHE WENT TO PLACE A GROOVE IN CENTER OF THE LENS FOR A DIVIDE AND CONQUER TECHNIQUE IT DROPPED TO THE BACK OF THE EYE IMMEDIATELY. THE LENS WAS RETRIEVED BY A RETINA COLLEAGUE AT THE FACILITY AND A PARS PLANA VITRECTOMY WAS DONE. A SULCUS IOL WAS ABLE TO BE PLACED. AT DAY 1 THE PATIENT APPEARED TO BE DOING OKAY. NO PREVIOUS EYE SURGERIES OR INJURIES WERE NOTED.

    Description of Event or Problem · 0

    (B)(4) ISSUE: ON (B)(6) 2022, (B)(6) ((B)(4)) REPORTED TO (B)(6) THAT DR. (B)(6) HAD A WHAT APPEARED TO BE A "VERY LARGE BUBBLE" (B)(4). (B)(6) STATED THAT THE BAG COLLAPSED AS SOON AS DR. (B)(6) WENT INTO THE EYE. SITE IS REQUESTING THAT THE CASE BE REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096259 LENSAR LASER SYSTEM-FS 3D LENSAR LASER SYSTEM-FS 3D OOE LENSAR, INC N/A N/A 10867744000119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other