BEUDAMED
    FDA Adverse Event Other Summary report: N

    LENSAR LASER SYSTEM - FS 3D

    MDR report key: 4621237 · Received November 17, 2014

    Report

    Report Number
    3009026057-2014-00032
    Event Type
    Other
    Date Received
    November 17, 2014
    Date of Event
    October 21, 2014
    Report Date
    November 14, 2014
    Manufacturer
    LENSAR INC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IDENTIFIES TWO CASES WHERE THE CAPSULOTOMIES HAD ATTACHMENT POINTS AND WERE NOT FREE FLOATING. SEVERAL ATTEMPTS WERE MADE TO GET ONE PT SURGICAL FILE, BUT THE FILE WAS NOT RECEIVED BY LENSAR. ONLY ONE OF THE FILES WAS SUBMITTED FOR REVIEW. UPON REVIEW WHAT IS EASILY RECOGNIZED IS THAT THE EYECUP IS VERY DECENTERED BY AS MUCH AS 1.5 - 2.0 MM. THIS IS EASILY SEEN IN THE DOWN THE PIPE IMAGE. THE SURGEON SHOULD HAVE STOPPED THERE AND REAPPLIED THE EYECUP THEN RE-DOCK AS IS DESCRIBED DURING CLINICAL TRAINING. IN THIS INSTANCE, THE SURGEON CONTINUED. SECONDLY, WHILE SCANNING, THE IMAGES SHOWED THAT THE LENS IS VERY MUCH TILTED EVEN THOUGH THE CORNEA AND LENS SURFACES ARE AUTOMATICALLY DETECTED. THE SURGEON WOULD HAVE BEEN ABLE TO SEE THAT THE LENS ANTERIOR SURFACE, ON A LENS THAT IS SO SEVERELY TILTED, FALLS IN AND OUT OF THE REGION OF INTEREST. A THIRD INDICATOR IS DURING THE 3D-RECONSTRUCTION, THE DISPLAY SHOWS AN OPTICAL TILT OF 8.3 DEGREES. WITH ALL THE INDICATORS PRESENTED BY THE LASER SYSTEM THE SURGEON ELECTED TO CONTINUE WITH THE TREATMENT PLAN. ON (B)(6) 2014, THE DAY BEFORE THE EVENT OCCURRED A LENSAR FSE WAS AT THE CLINICAL SITE FOR A SURGERY DAY ATTENDANCE AND NO SYSTEM MALFUNCTION OR CLINICAL EVENTS WERE REPORTED. IN ADDITION, THERE HAVE BEEN NO COMPLAINTS FOR SYSTEM MALFUNCTION REPORTED BY THE CLINICAL SITE AFTER THE EVENT OCCURRED. THE SYSTEM FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    A LENSAR CLINICAL APPLICATION SPECIALIST REPORTED THAT WHILE ON A CLINICAL SITE FOR A SOFTWARE UPGRADE TRAINING, THE DOCTOR HAD W CASES THAT THE CAPSULOTOMY WAS NOT FREE FLOATING AT OR AROUND THE 2 O'CLOCK AREA (45-90 DEGREES). ONE OF THE CASES ENDED UP WITH AN ANTERIOR CAPSULE TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743589 LENSAR LASER SYSTEM - FS 3D LENSAR LASER SYSTEM -FS 3D OOE LENSAR INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other