BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORIA AUTOMATED LAMELLAR THERAPEUTIC KERATOPLASTY SYSTEM

    MDR report key: 462863 · Received May 29, 2003

    Report

    Report Number
    2529598-2003-00001
    Event Type
    Injury
    Date Received
    May 29, 2003
    Date of Event
    January 17, 2003
    Report Date
    May 27, 2003
    Manufacturer
    MORIA, S.A.
    Product Code
    HNO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS SCHEDULED TO UNDERGO A LAMELLAR ENDOTHELIAL TRANSPLANT, OT PARTIAL-THICKNESS CORNEAL TRANSPLANT IN 2003. THIS PARTIAL TRANSPLANT WAS BEING DONE TO AVOID A FULL PENETRATING HERATOPLASTY OR TRADITIONAL CORNEAL TRANSPLANT. AS PART OF THIS PROCEDURE, THE PHYSICIAN USED THE MORIA ALTK MICROKERATOME SYSTEM WITH THE 350 LSK ONE HEAD TO CREATE A HINGED ANTERIOR FLAP IN THE PT'S EYE. THE PT'S PACHYMETRY READINGS INDICATED THAT THEIR CORNEAL WAS 500 MICRONS THICK. THE MICROHERATOME BLADE REPORTEDLY ENTERED THE ANTERIOR CHAMBER OF THE EYE RESULTING IN TRAUMA TO THE TEMPORAL IRIS AND CITREOUS LOSS. AFTER THE INCIDENT, THE PHYSICIAN REPOSITIONED THE IRIS AND THE VITREOUS AND THEN PLACED SUTURES TO STABILIZED THE EYE. THE PT WILL UNDERGO THE FULL PENETRATING KERATOPLASTY OR TRADITIONAL CORNEAL TRANSPLANT IN ABOUT SIX TO TWELVE MONTHS AND IS NOT EXPECTED TO HAVE ANY LONG-TERM ADVERSE EFFECTS FROM THIS INCIDENT. AFTER CONSULTATION WITH THE PHYSICIAN INVOLVED AND SEVERAL OTHER PHYSICIANS WITH EXPERTISE IN PERFORMING THSI PROCEDURE, IT APPEARS THAT THIS INCIDENT RESULTED FROM THE USE OF A 350 MICRO HEAD INSTEAD OF A SMALLER HEAD. ACCORDING TO THE MORIA INSTRUCTION MANUAL, A 350 HEAD WILL YIELD A 400 TO 430 MICRON THICK CUT IN THE CORNEA. FOR A CORNEA OF 500 MICRONS IN THICKNESS, A SMALLER LSK ONE HEAD (E.G., A 250 MICRON HEAD) IS GENERALLY INDICATED. IT ALOS APPEARS THAT A SLOW PASS WAS MADE IN CUTTING THE FLAP, WHICH ALSO COULD HAVE CONTRIBUTED TO A THICKER THAN NORMAL CUT. THE LEVEL IF INNER OCULAR PRESSURE, SELECTION OF THE SUCTION RING, AND THE ACCURACY OF THE KERITOMETRY READINGS ARE ALSO FACTORS IN DETERMINING FLAP THICKNESS. HOWEVER, MORIA DOES NOT HAVE ANY INFO CONCERNING THOSE ADD'L FACTORS. THE CO HAS NOT REPORTED THIS MATTER UNTIL NOW DUE TO DELAYS IN RECEIVING INFO NECESSARY TO DETERMINE THE CAUSE OF THE THICKER FLAP AND THE NATURE OF THE PT'S CONDITION AND PROGNOSIS. BASED ON THE CO'S INVESTIGATION TO DATE, IT DOES NOT APPEAR THAT THE MORIA ALTK SYSTEM WAS DEFECTIVE OR MALFUNCTIONED IN ANY WAY. IN FACT, THE PHYSICIAN REPORTS THAT HE HAS NOT HAD ANY OTHER INCIDENTS WITH THE MORIA ALTK AND THAT IT IS WORKING FINE. THE PHYSICIAN IS IN THE PROCESS OF RETURNING THE MICROKERATOME TO MORIA FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MORIA AUTOMATED LAMELLAR THERAPEUTIC KERATOPLASTY SYSTEM MICROKERATOME HNO MORIA, S.A. ALTK/1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention