BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CB MICROKERATOME

    MDR report key: 3641100 · Received February 4, 2014

    Report

    Report Number
    9615659-2014-00001
    Event Type
    Injury
    Date Received
    February 4, 2014
    Date of Event
    October 1, 2004
    Report Date
    January 21, 2014
    Manufacturer
    MORIA SA
    Product Code
    HMY
    PMA / PMN Number
    K981741
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY, (B)(6), WHERE THE SURGERY WAS PERFORMED, PURCHASED THE DEVICE IN (DECEMBER 2001). BASED ON THE INFO AVAILABLE TO MORIA, IT APPEARS THAT THE PT UNDERWENT LASIK SURGERY ON BOTH EYES ON (B)(6) 2004. THIS TYPE OF SURGERY INVOLVES DIFFERENT MEDICAL DEVICES, INCLUDING A MICROKERATOME, WHICH IS A SURGICAL INSTRUMENT THAT CUTS THE FLAP IN THE CORNEA DURING THE SURGERY, AS WELL AS AN EXCIMER LASER THAT IS USED TO RESHAPE THE CORNEA AFTER THE FLAP IS PULLED BACK. MORIA'S CB MICROKERATOME WAS USED IN THE PROCEDURE IN QUESTION. APPROX 15 MONTHS AFTER THE LASIK PROCEDURE, THE PT REPORTED DEVELOPMENT OF A KERATECTASIA (I.E., ABNORMAL BULGING OF THE CORNEA) IN EACH EYE. KERATECTASIA IS MOST COMMONLY TREATED WITH THE USE OF CORRECTIVE CONTACT LENSES; IN SOME INSTANCES, HOWEVER, PENETRATING KERATOPLASTY IS REQUIRED TO CORRECT THE CONDITION (WITH A HIGH RATE OF SUCCESS). MORIA FIRST LEARNED OF THIS INCIDENT ON 01/7/2014 WHEN IT WAS NOTIFIED OF A LIABILITY CASE BROUGHT IN (B)(4) BY THE PT AGAINST THE PHYSICIAN WHO PERFORMED THE PROCEDURE. THE ONLY INFO AVAILABLE TO MORIA ABOUT THE POTENTIAL CAUSE OF THE KERACTASIA IS THE ALLEGATION THAT "[T]HE STROMA RESIDUAL THICKNESS IS TOO THIN AND IS AT THE ORIGIN OF THE BILATERAL KERATECTASIA." HOWEVER, THERE IS NO EVIDENCE THAT THE THICKNESS OR THINNESS OF THE STROMA WAS AFFECTED BY THE MICROKERATOME OR THAT DEVELOPMENT OF A KERATECTASIA WAS OTHERWISE ATTRIBUTABLE TO THE USE OF THE CB MICROKERATOME. OTHER NON-MORIA EQUIPMENT (E.G., EXCIMER LASER) IS ALSO USED DURING THE PROCEDURE AND THAT OR OTHER FACTORS COULD HAVE CAUSED THE THINNESS OF THE STROMA. CLINIQUE DUR MERIDIEN, THE FACILITY WHERE THE SURGERY WAS PERFORMED, BOUGHT THE DEVICE FROM MORIA IN DECEMBER 2001 AND, TO MORIA'S KNOWLEDGE, BEGAN USING THE EQUIPMENT IN JANUARY 2002. AT THE TIME OF PURCHASE, THE FACILITY ALSO PURCHASED FOUR SETS OF REPLACEMENT PARTS FOR THE EQUIPMENT AND MORIA HAS NO RECORD OF ANY SIMILAR INCIDENTS OCCURRING AT THIS FACILITY. MORIA REGARDS THIS AS AN ISOLATED INCIDENT. HOWEVER, BASED ON THE INFO AVAILABLE TO IT, MORIA DOES NOT BELIEVE THAT THE INCIDENT WAS CAUSED BY ANY MALFUNCTION OR DEFECT IN THE CB MICROKERATOME OR THAT THE MICROKERATOME IN ANY OTHER WAY CAUSED OR CONTRIBUTED TO THE OUTCOME OF THIS SURGERY. AS MORIA DOES NOT BELIEVE THAT THE INCIDENT WAS CAUSED OR CONTRIBUTED TO BY THE DEVICE, THIS REPORT IS SUBMITTED OUT OF AN ABUNDANCE OF CAUTION AN ONLY BECAUSE THE PT ALLEGED A SERIOUS INJURY THAT APPEARS TO HAVE REQUIRED A CORRECTIVE PROCEDURE TO PREVENT PERMANENT IMPAIRMENT OF THE PT'S VISION.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A BILATERAL LASIK SURGERY IN WHICH A MORIA CB MANUAL MICROKERATOME HAD BEEN USED. THE SURGERY TOOK PLACE IN (B)(6) 2004 IN (B)(6). AT 15 MONTHS LATER, THE PATIENT DECLARED A DOUBLE KERATECTASIA. ONE IN EACH EYE. THE ONLY INFORMATION WE HAVE IS WHAT WAS MENTIONED IN A JUDICIAL ASSIGNMENT RECEIVED ON JANUARY 7, 2014: "THE STROMA RESIDUAL THICKNESS IS TOO THIN AND IS AT THE ORIGIN OF THE BILATERAL KERATECTASIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73551 CB MICROKERATOME KERATOME HMY MORIA SA 19303 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention