BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORIA ONE USE PLUS MICROKERATOME

    MDR report key: 2906344 · Received January 7, 2013

    Report

    Report Number
    9615659-2013-00001
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    September 16, 2010
    Manufacturer
    MORIA S.A.
    Product Code
    HMY
    PMA / PMN Number
    K040297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MORIA FIRST LEARNED OF THIS INCIDENT ON (B)(6) 2012, AND ONLY LEARNED THAT THE PATIENT ALLEGED AN INJURY THAT REQUIRED MEDICAL FOLLOW-UP ON (B)(6) 2012. (B)(6) EYE CENTER, THE FACILITY WHERE THE SURGERY WAS PERFORMED, BOUGHT THE DEVICE FROM MORIA IN (B)(4) 2006. MORIA'S RECORDS INDICATE THE DEVICE WAS LAST SERVICED IN (B)(4) 2008. THE DEVICE HAS NOT BEEN SERVICED BY MORIA SINCE THEN, DESPITE SENDING REMINDERS TO (B)(6) EYE CENTER IN (B)(4) 2009 AND LATE 2010/ EARLY 2011 REGARDING THE NEED FOR SERVICING OF THE DEVICE. THIS IS AN ISOLATED INCIDENT. MORIA'S INVESTIGATION CONCLUDES THAT THE INCIDENT WAS NOT CAUSED BY ANY MALFUNCTION OR DEFECT IN THE MICROKERATOME CONTROL UNIT OR MOTOR. AS MORIA DOES NOT BELIEVE THA THE INCIDENT WAS CAUSED OR CONTRIBUTED TO BY THE DEVICE, THIS REPORT IS SUBMITTED OUT OF AN ABUNDANCE OF CAUTION AND ONLY BECAUSE THE PATIENT ALLEGED A SERIOUS INJURY THAT APPARENTLY REQUIRED A CORRECTIVE PROCEDURE TO PREVENT PERMANENT IMPAIRMENT OF HIS VISION.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT LASIK SURGERY ON HIS RIGHT EYE ON (B)(6) 2010. LASIK SURGERY INVOLVES DIFFERENT COMPONENTS, INCLUDING A MICROKERATOME, WHICH IS A SURGICAL INSTRUMENT THAT CUTS THE FLAP IN THE CORNEA DURING THE SURGERY. WE BELIEVE MORIA'S ONE USE PLUS MICROKERATOME SYSTEM, CONSISTING OF AN EVOLUTION 3E MICROKERATOME CONTROL UNIT, A ONE USE PLUS HANDPIECE, STERILE ASPIRATION TUBING, AND A ONE USE PLUS HEAD AND RING, WAS USED IN THE PROCEDURE IN QUESTION. THE SURGERY RESULTED IN A FREE (RATHER THAN HINGED) FLAP. THIS IS KNOW COMPLICATION OF LASIK SURGERY. THE SURGEON REPLACED THE FREE FLAP AND DISCONTINUED SURGERY ON THE RIGHT EYE. A LASIK PROCEDURE WAS COMPLETED ON THE LEFT EYE DURING THE SAME SESSION, WITHOUT INCIDENT. THE PATIENT SUBSEQUENTLY COMPLAINED OF BLURRED VISION IN THE RIGHT EYE. HE EVENTUALLY UNDERWENT A PHOTOREFRACTIVE KERATECTOMY (PRK) PROCEDURE, WHICH REPORTEDLY CORRECTED THE BLURRED VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8177 MORIA ONE USE PLUS MICROKERATOME KERATOME HMY MORIA S.A. 19345 (MOTOR) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention