BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK MK-2000 KERATOME

    MDR report key: 1032770 · Received April 23, 2008

    Report

    Report Number
    2936921-2008-00001
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 27, 2008
    Report Date
    April 22, 2008
    Manufacturer
    NIDEK CO, LTD
    Product Code
    HNO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING IS A DESCRIPTION OF THE EVENT AS RELAYED TO NIDEK INC BOTH VERBALLY AND ON THE MK COMPLAINT FORM BY VISION CENTER: IN 2008, THE PHYSICIAN WAS CREATING A TEMPORAL INCISION ON THE PT'S MYOPIC RIGHT EYE, WITH THE MK-2000 HAND PIECE, 180UM BLADE HOLDER AND THE 9.0MM SUCTION RING COMBINATION. THE MICROKERATOME WAS PLACED ON THE CORNEA, GOOD SUCTION OBTAINED AND NOTED. KERATOME "BUCKED" AND STOPPED. PHYSICIAN STATED "KERATOME APPEARED TO HAVE JAMMED INTO THE LID SPECULUM." THE MICROKERATOME WAS REMOVED FROM THE PT'S EYE AND REINSPECTED, PROPER ASSEMBLY CONFIRMED, WEDGE IN PLACE AND FULL TEST RUN PERFORMED. "ALL APPEARED NORMAL." SUCTION RING WAS PLACED BACK ON THE CORNEA AND SUCTION ACQUIRED. MICROKERATOME ADVANCED AND IMMEDIATELY STOPPED WHEN SUCTION WAS LOST. MICROKERATOME WAS REMOVED FROM THE PT'S EYE. "ANTERIOR CHAMBER NOTED TO BE FLAT, BUT ANATOMICALLY INTACT." "ANTERIOR CHAMBER FILLED WITH VISCOAT AS LARGE OPENING TEMPORAILY WHERE KERATOME ENTERED THE EYE." A BANDAGE CONTACT LENS WAS PLACED AND PT WAS GIVEN VIGAMOX. PATIENT WAS TRANSPORTED TO THE OPERATING ROOM AND THE CORNEA WAS SUTURED. THE FOLLOWING MONTH, DR'S HANDPIECE AND BLADE HOLDER WERE RECEIVED AT NIDEK INC. FOR INSPECTION. PRIOR TO THE INSPECTION, IT WAS FOUND THAT THIS MICROKERATOME HAD NOT BEEN SERVICED FOR 3 YEARS. DURING THE INSPECTION, THE TECHNICIAN FOUND THE HAND PIECE TO BE OUT OF SPECIFICATION AND THE BLADE HOLDER HAD DAMAGE ON THE SURFACE. IT IS NIDEK'S CONCLUSION THAT THE PROBLEMS FOUND WITH THE MICROKERATOME DID NOT ATTRIBUTE TO THE INCIDENT OF THE PERFORATED CORNEA. IT HAS BEEN DETERMINED AS USER ERROR.

    Description of Event or Problem · 1

    ON 03/31/08, NIDEK INC REC'D REPORT OF AN ADVERSE EVENT FROM FACILITY. REP REPORTED THAT WHILE USING THE MK-2000, THE PATIENT'S ANTERIOR CHAMBER OF THE RIGHT CORNEA WAS PERFORATED, ON THE TEMPORAL SIDE OF THE EYE. REP STATED THAT THE PERFORATION WAS NOT NEAR THE VISUAL AXIS AND THAT THE PT'S VISION WAS NOT AFFECTED. THE PT REQUIRED 3 SUTURES ON THE CORNEA. DR STATED THAT DURING THE PROCEDURE THE MK-2000 (KERATOME) MAY HAVE COME IN CONTACT WITH THE LID SPECULUM WHILE CREATING THE CORNEAL FLAP CAUSING THE KERATOME TO "DIVE" INTO THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIDEK MK-2000 KERATOME KERATOME, AC POWERED HNO NIDEK CO, LTD MK-2000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention