BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORIA EVOLUTION II

    MDR report key: 1028547 · Received April 16, 2008

    Report

    Report Number
    2529598-2008-00001
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    January 25, 2008
    Report Date
    April 4, 2008
    Manufacturer
    MORIA S.A.
    Product Code
    HMY
    PMA / PMN Number
    K980924
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DR REPORTED THE INCIDENT IN 2008. EYE AND SURGERY, THE FACILITY AT WHICH THE SURGERY WAS PERFORMED, RETURNED THE MICROKERATOME CONSOLE AND TURBINE THAT WERE USED IN THE PROCEDURE TO MFR ON EIGHT DAYS LATER. THE FACILITY BOUGHT THE DEVICE FROM MFR IN1998, BUT MORIA HAS NO RECORDS OF THIS MACHINE BEING RETURNED FOR SERVICING BEFORE THIS INCIDENT. MORIA EXAMINED THE CONSOLE AND TURBINE. IT FOUND THAT THE BATTERY WAS NOT THE ORIGINAL, AND INSTEAD IT WAS A DIFFERENT BRAND AND MODEL THAT WAS NOT PROVIDED BY MORIA. THE MAXIMUM VOLTAGE AFTER CHARGE WAS 12.09 VOLTS, INSTEAD OF 13.9 VOLTS FOR A BRAND NEW BATTERY. THE BATTERY WAS OUTSIDE OF MORIA'S SPECIFICATIONS. THE INSTRUCTION MANUAL FOR THE MACHINE STATES THAT ONLY MORIA BATTERIES SHOULD BE USED, AND THE USE OF A DIFFERENT BATTERY CAN RESULT IN DAMAGE OF THE UNIT OR MALFUNCTIONING. THE RELEVANT PAGES FROM THE INSTRUCTION MANUAL ARE ATTACHED. IN ADDITION, THE TURBINE SHOWED HEAVY DEPOSITS. THE PERFORMANCE OF THE TURBINE REMAINED IN COMPLIANCE WITH MORIA'S TECHNICAL SPECIFICATIONS. MORIA'S EXAMINATION ALSO FOUND THAT A BROKEN TURBINE HOSE WAS SCREWED ON THE FRONT PANEL CONNECTOR. THE SILICONE TUBES OF THE VACUUM CIRCUIT WERE A DIRTY-BROWN OR YELLOW COLOR, INDICATING POSSIBLE PRESENCE OF WATER OR LIQUID. THE VACUUM LEVEL WAS IN COMPLIANCE WITH MORIA'S TECHNICAL SPECIFICATIONS, BUT BOTH PUMPS WERE UNSTABLE. MORIA SENT MANHATTAN EYE, EAR AND SURGERY A LETTER IN 2007, REMINDING THE CO OF THE NEED TO HAVE THE MACHINE SERVICED. DURING THE EXAMINATION MORIA FOUND STICKERS ON THE DEVICE FROM OTHER COMPANIES, INDICATING THAT IT MAY HAVE BEEN SERVICED BY THESE COMPANIES. HOWEVER, EXCEPT FOR THE REPLACEMENT OF THE BATTERY AS EXPLAINED ABOVE, MORIA DID NOT FIND ANY PROOF OF SERVICE DONE ON THE EQUIPMENT. THIS IS AN ISOLATED INCIDENT. MORIA CONCLUDES THAT THE INCIDENT WAS NOT CAUSED BY THE MICROKERATOME CONTROL UNIT, AND COULD HAVE BEEN CAUSED BY PT-RELATED FACTORS.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT LASIK SURGERY IN 2008. LASIK SURGERY INVOLVES DIFFERENT COMPONENTS, INCLUDING A MICROKERATOME, WHICH IS A SURGICAL INSTRUMENT THAT CREATES A CORNEAL FLAP DURING THE SURGERY. MORIA'S LSK EVOLUTION 2 MICROKERATOME CONTROL UNIT WAS USED IN THE PROCEDURE ON THE SAME DAY. NOTHING WAS REPORTED TO BE OUT OF THE ORDINARY DURING SURGERY, AND THE CONTROL UNIT FUNCTIONED PROPERLY DURING THE PROCEDURE. TEN DAYS AFTER THE SURGERY, THE PT WAS HAVING DIFFICULTY SEEING OUT OF ONE OF HER EYES. ACCORDING TO THE PHYSICIAN WHO PERFORMED THE SURGERY, THE PT WAS HAVING CHORIODAL ARTERY TROUBLE AND WAS REFERRED TO A NEURO-OPHTHALMOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MORIA EVOLUTION II EVOLUTION II CONSOLE HMY MORIA S.A. 19350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other