BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AL-SCAN VIEWER FOR NAVIS-EX

    MDR report key: 11944806 · Received June 7, 2021

    Report

    Report Number
    8030392-2021-00002
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 7, 2021
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    NFJ
    PMA / PMN Number
    K181345
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IOL POWER CAN BE CALCULATED WHEN THE NECESSARY MEASUREMENT RESULTS ARE SAVED IN AL-SCAN VIEWER. IT HAS ALREADY BEEN CONFIRMED THAT THE IOL POWER WAS CALCULATED BY SELECTING OTHER PATIENT DATA WITHOUT CHECKING MEASUREMENT DATA. OWING TO THE ABOVE PROCEDURE, THE PATIENT IN QUESTION WAS IMPLANTED WITH THE WRONG IOL POWER, RESULTING IN 5D OFF TARGET. THE CUSTOMER SELECTED OTHER PATIENT'S DATA AND ONLY CHANGED THE AXIAL LENGTH TO CALCULATE THE IOL POWER. (IT IS GENERALLY KNOWN THAT THE KERATOMETRY DATA IS ALSO NECESSARY FOR IOL CALCULATION.) IN THE IOL CALCULATION SCREEN, DATA EDITED BY MANUAL INPUT WILL BE IDENTIFIED BY SYMBOLS (AND RED TEXT WHEN EDITING). IT HAS BEEN APPROX. FIVE YEARS SINCE AL-SCAN VIEWER WAS RELEASED IN THE GLOBAL MARKET, HOWEVER, THERE HAVE BEEN NO SIMILAR EVENTS. THE FOLLOWING INFORMATION IS PROVIDED IN THE INSTRUCTION MANUAL (IFU). BE SURE TO HAVE THE DATA MEASURED OR CALCULATED USING THE AL-SCAN CHECKED BY THE DOCTORS BEFORE USE. CAREFULLY EVALUATE THE VALIDITY OF THE MEASUREMENT RESULTS FROM THE STEADINESS OF THE MEASUREMENT VALUES AND WAVEFORMS. IF THE MEASUREMENT DOES NOT SEEM TO BE CORRECT, PERFORM THE MEASUREMENT AGAIN, OR REFER TO OTHER MEASUREMENT RESULTS. IF AN IOL POWER CALCULATION RESULT OBTAINED WITH INCORRECT MEASUREMENT RESULTS IS USED TO SELECT AN INTRAOCULAR LENS, REOPERATION MAY RESULT. WHEN THE IOL POWER HAS BEEN CALCULATED USING AN AXIAL LENGTH VALUE CORRECTED USING THE AL OFFSET, DECIDE WHETHER OR NOT TO USE THE CALCULATED IOL POWER TAKING THAT INTO CONSIDERATION. NIDEK CO., LTD. CONSIDERS THIS ISSUE A REPORTABLE EVENT AS IT IS AN UNDESIRABLE CONDITION AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUES WERE RECUR.

    Description of Event or Problem · 1

    ON MAY 20, 2021, NIDEK CO., LTD. RECEIVED AN INFORMATION FROM THE CUSTOMER TO REPORT THAT A LARGE POWER GAP HAD IN A PATIENT WHO USED AL-SCAN VIEWER (*1) TO CALCULATE IOL POWER. IT HAS ALREADY BEEN CONFIRMED THAT THE IOL POWER WAS CALCULATED BY SELECTING OTHER PATIENT DATA WITHOUT CHECKING MEASUREMENT DATA. OWING TO THE ABOVE PROCEDURE, THE PATIENT IN QUESTION WAS IMPLANTED WITH THE WRONG IOL POWER, RESULTING IN 5D OFF TARGET. CURRENTLY, IOL REPLACEMENT FOR THE PATIENT IN QUESTION HAS BEEN COMPLETED. AL-SCAN VIEWER IS OPTIONAL SOFTWARE FOR NIDEK OPTICAL BIOMETER (MODEL: AL-SCAN). IT CAN BE ADDED AS A PLUG-IN TO PC ON WHICH NAVIS-EX, THE DATA MANAGEMENT SOFTWARE FOR NIDEK'S MEASURING INSTRUMENTS, IS INSTALLED TO DISPLAY MEASUREMENT DATA, WAVEFORMS AND CALCULATE IOL POWER. IOL POWER CAN BE CALCULATED WHEN THE NECESSARY MEASUREMENT RESULTS ARE SAVED IN AL-SCAN VIEWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846219 AL-SCAN VIEWER FOR NAVIS-EX AL-SCAN VIEWER FOR NAVIS-EX NFJ NIDEK CO., LTD. AL-SCAN VIEWER FOR NAVIS-EX SOFTWARE VERSION 1.3.1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention