BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EC-5000CXIII(QUEST M2)

    MDR report key: 9456034 · Received December 12, 2019

    Report

    Report Number
    8030392-2019-00008
    Event Type
    Injury
    Date Received
    December 12, 2019
    Report Date
    February 18, 2020
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AGAINST AN INITIAL REPORT FROM CUSTOMER, SERVICE ENGINEER OF NIDEK AUTHORIZED DISTRIBUTOR(MD VISION) IN RUSSIA INSPECTED THE EC5000CXIII AND NO ABNORMALITY WAS FOUND ON THE DEVICE. AFTER THE INITIAL REPORT, WE OBTAINED PRE-OPERATION DATA, OPERATION SETTING(LASER SETTING) AND POST-OPERATION DATA OF SEVEN PATIENTS WHO COMPLAINED OF THE SYMPTOMS THROUGH NIDEK AUTHORIZED RUSSIAN DISTRIBUTOR(MD VISION). WE EVALUATED THE INFORMATION. AS A RESULT, THE AVERAGE OF POST-OPERATIVE SE(SPHERICAL EQUIVALENT) VALUE WAS 0.39(CONSIDERED AS EMMETROPIA). THEREFORE, NO OVERCORRECTION WAS OBSERVED FROM PATIENTS' DATA. CUSTOMER DECIDED TO USE THE DEVICE BY THEMSELVES AND NO COMPLAINTS HAVE BEEN RECEIVED FROM THE CUSTOMER. INITIAL MDR WAS REPORTED THAT "THE CUSTOMER CANCELLED THE GAS EXCHANGE MESSAGE AND CONTINUED THE OPERATION", IT WAS NOT APPROPRIATE HANDLING BY CUSTOMER. HOWEVER, IT WAS NOT RELATED TO THIS COMPLAINT ACCORDING TO THE TIME LOG (RECORD OF OPERATION). BASED ON THE ABOVE RESULTS, NO OCCURRENCE OF OVERCORRECTION WAS OBSERVED FROM PATIENTS' DATA, AND NO ABNORMALITY ON THE DEVICE WAS CONFIRMED.

    Description of Event or Problem · 0

    PLEASE SEE INITAL MDR SUBMITTION ON 12-DEC-2020.

    Additional Manufacturer Narrative · 1

    WE OBTAINED THE DATA FOR 57 PATIENTS WHO WERE TREATED FROM (B)(6) 2019 TO (B)(6) 2019. THE SERVICE ENGINEER REPORTED THAT 7 OUT OF 57 PATIENTS COMPLAINED OF THE RESULT. (FIRST REPORT FROM CUSTOMER MENTIONED THAT OVER CORRECTION OCCURRED FOR 10 PATIENTS, BUT AFTER THAT, IT WAS OBSERVED THAT 7 OUT OF 57 PATIENTS COMPLAINED OF THE RESULT, NOT 10 PATIENTS.) CHECKING POSTOPERATIVE PATIENT DATA, 1 PATIENT WAS + 1.5D, 2 PATIENTS WAS +0.5 TO + 0.7D AND 4 PATIENTS WERE +0.1 TO 0.5D. WE REVIEWED THE DHR OF THE DEVICE AND CONFIRMED THAT ALL ITEMS MET THE REQUIREMENT OF THE QUALITY CRITERIA AT THE FINAL INSPECTION. NO PROBLEM WAS FOUND ON THE DEVICE. WE ASKED THE CUSTOMER TO STOP USING THE DEVICE TO INVESTIGATE THE CAUSE FROM (B)(6) 2019. NIDEK OBTAINED THE LOG DATA OF THE DEVICE VIA THE SERVICE ENGINEER. THE DEVICE HAS BEEN CALIBRATED BY THE CUSTOMER. WE CONFIRMED THAT THE MESSAGE FOR NEW-FILL OF THE GAS EXCHANGE WAS INDICATED VIA THE LOG DATA, HOWEVER THE CUSTOMER CANCELED THE MESSAGE AND CONTINUED TO USE THE DEVICE.

    Description of Event or Problem · 1

    NIDEK AUTHORIZED DISTRIBUTOR (MD VISION) IN (B)(6) INFORMED NIDEK CO.,LTD THAT OVER-CORRECTION OCCURRED FOR 10 PATIENTS WHO WERE TREATED WITH NIDEK EC-5000CXIII(QUEST M2) (B)(4). SERVICE ENGINEER VISITED THE SITE TO INSPECT THE DEVICE AFTER RECEIVING THE INFORMATION, AND THEY FOUND THAT THE DEVICE WAS WORKING PROPERLY AND NO PROBLEM WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256925 EC-5000CXIII(QUEST M2) EXCIMER LASER QUEST LZS NIDEK CO., LTD. EC-5000CXIII(QUESTM2)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention