BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK MK-2000 KERATOME

    MDR report key: 377083 · Received February 15, 2002

    Report

    Report Number
    2936921-2002-00001
    Event Type
    Injury
    Date Received
    February 15, 2002
    Date of Event
    January 1, 2001
    Report Date
    February 15, 2002
    Manufacturer
    NIDEK CO LTD
    Product Code
    HNO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NIDEK INC LEARNED OF THE FOLLOWING EVENT FROM AN ARTICLE PUBLISHED IN THE AMERICAN JOURNAL OF OPHTHALMOLOGY 2001; 132 (6):920-921. A PT WAS TO UNDERGO A LASIK PROCEDURE ON THE EYE DUE TO COMPOUND MYOPIC ASTIGMATISM. FOLLOWING THE NIDEK MK-2000 MICROKERATOME PASS, IT WAS REPORTED BY THE PRIMARY SURGEON THAT THE CONREAL FLAP WAS OBSERVED TO BE AN "IRREGULAR, JAGGED FLAP". THE LASIK PROCEDURE WAS ABORTED, AND THE PRIMARY KERATOTOMY FLAP WAS IMMEDIATELY REPOSITIONED. AT 11 DAYS POSTOPERATIVE THE "BSCVA" WAS 20/100 WITH A MANIFEST REFRACTION OF -20.0 +5.50 X 120. SLIT LAMP EXAMINATION DEMONSTRATED A NASAL HINGED PRIMARY KERATOTOMY FLAP AT 90% DEPTH THROUGH THE CORNEAL STROMA WITH EVIDENCE OF CENTRAL ECTASIA. AT ONE MONTH POSTOPERATIVE, THE "BSCVA" WAS 20/100 WITH A MANIFEST REFRACTION OF -30.0 +8.50 X 100. THE ECTASIA HAD PROGRESSED, AND THE PT UNDERWENT FITTING FOR A RIGID GAS PERMEABLE CONTACT LENS AND WAS BEING CONSIDERED FOR POSSIBLE PENETRATING KERATOPLASTY.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R| S