BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 2841972 · Received November 14, 2012

    Report

    Report Number
    3008772169-2012-00036
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ALC N - L NSX LAS S, NC.
    Product Code
    OOE
    PMA / PMN Number
    K1 1626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE ENGINEER REPLACED THE GANTRY AND THE JOYSTICK. THE COMPONENTS HAVE BEEN RETURNED TO THE MFR AND THE INVESTIGATION IS UNDERWAY. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE NURSE REPORTED UNINTENDED GANTRY MOVEMENT. WHEN THE SURGEON MOVED THE GANTRY DOWN TOWARD THE PT TO DOCK, HE STOPPED THE JOYSTICK, BUT THE GANTRY CONTINUED TO MOVE DOWN COMING IN CONTACT WITH THE PT'S EYE. THE SURGEON PASSED THE EMERGENCY SHUT-OFF BUTTON AND REMOVED THE PT FROM UNDER THE LASER SYSTEM. THE NURSE INDICATED THAT THE PT'S ORBIT WAS RED AND THEY WERE MONITORING FOR ANY SIGNS OF INJURY. SHE STATED THE PT'S INTRAOCULAR PRESSURES WERE NORMAL AND NO ADD'L TREATMENTS WERE REQUIRED. THE SURGEON PROVIDED THE FOLLOWING ACCOUNT OF THE EVENT. ONCE HE STOPPED USING THE JOYSTICK, THE GANTRY CONTINUED TO MOVE DOWN AND MAKE CONTACT WITH THE PT. THE TECH WAS ATTEMPTING TO MOVE THE JOYSTICK UP, BUT THE SYSTEM DID NOT RESPOND. HE STATED THE EMERGENCY SWITCH WAS HIT AND THE SYSTEM RETURNED TO ITS HOME POSITION. HE INDICATED WHEN THE EVENT OCCURRED, HE THOUGHT THAT THE GLOBE HAD RUPTURED, HOWEVER, UPON EVAL, THE PT'S EYE WAS DISCOVERED TO BE RED WITH NO IMPACT TO THE ORBIT. HE INDICATED THE PT WAS EXAMINED A COUPLE HOURS LATER AND THE EYE WAS STILL A LITTLE RED, BUT HE DID NOT SEE ANY BLOOD OR CELLS WITHIN THE EYE. HE STATED THERE WAS NO IMPACT TO THE PT'S VISION AND VISION REMAINED 20/40 WITH THE CATARACT (SURGERY HAD BEEN POSTPONED). HE INDICATED THE INTRAOCULAR PRESSURE AND RETINA WERE GOOD. THE PT WAS PLACED ON DUREZOL AND BROMDAY. THE SURGEON PROVIDED AN UPDATE ON (B)(6) 2012, REPORTING THAT THE PT IS DOING WELL WITHOUT ANY UNTOWARD EFFECTS AND WILL LIKELY HAVE CATARACT SURGERY NEXT WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALC N - L NSX LAS S, NC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention