BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AL-SCAN

    MDR report key: 5752063 · Received June 27, 2016

    Report

    Report Number
    3002807715-2016-00023
    Event Type
    Injury
    Date Received
    June 27, 2016
    Date of Event
    February 1, 2016
    Report Date
    June 24, 2016
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HJO
    PMA / PMN Number
    K133132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INVESTIGATION INCLUDING INTERNAL TEST, THE NCO WAS ABLE TO DUPLICATE THE SIMILAR UNUSUAL AXIAL LENGTH AND WAVEFORMS BY ELECTRONIC DISCHARGE EXCEEDED THE CRITERIA. THE NCO CONSIDERED EXTERNAL ELECTROMAGNETIC DISTURBANCE IN ABNORMAL OPERATING CONDITIONS POSSIBLY MAY HAVE CAUSED TO AL-SCAN WHICH CONFORMS TO INTERNATIONAL STANDARDS FOR ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICE AND HAS BEEN VERIFIED TO OPERATE PROPERLY UNDER NORMAL OPERATING CONDITION. IN ORDER TO PREVENT THE INCIDENT IN CUSTOMER SITE IN THE UNITED STATES, NCO REQUESTED NIDEK INC. WHICH IS USA SUBSIDIARY OF NCO TO ALERT TO THIS SYMPTOM AND ALSO RECOMMENDED THAT THE SOFTWARE SHOULD BE UPGRADED WITH THE NEW VERSION.

    Description of Event or Problem · 1

    THE MANUFACTURER, NIDEK CO., LTD (ABBREVIATED: NCO). RECEIVED FOLLOWING INFORMATION FROM (B)(6) USER THROUGH NIDEK (B)(4)(ABBREVIATED (B)(4)) WHICH IS (B)(4) SUBSIDIARY OF NCO. ON MARCH 4TH, 2016, AXIAL LENGTHS WERE MEASURED BEFORE THE OPERATION OF IOLS' IMPLANTATION. THE RESULTS OF MEASUREMENT WERE 20.12MM/RIGHT EYE AND 20.10MM/LEFT EYE BEFORE THE OPERATION. AFTER THE OPERATION, THE AXIAL LENGTHS WERE RE-MEASURED DUE TO POOR VISION. THE AXIAL LENGTHS AFTER OPERATION WERE 22.80MM/RIGHT EYE AND 22.88MM/LEFT EYE AT THAT TIME ((B)(6) 2016). DUE TO THIS RESULT, THE USER INQUIRED TO (B)(4) ABOUT THIS SYMPTOM. BASED ON THE NEW RESULT, RE-OPERATION WAS CARRIED OUT, THE RESULT IS GOOD. WHEN CHECKING THE DATA OF THE MEASUREMENT RESULTS OF FRENCH FACILITY, NCO CONFIRMED THE MEASUREMENT RESULT OF UNUSUAL AXIAL LENGTH AND WAVEFORMS AT THE RIGHT END PORTION OF THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407406 AL-SCAN OPTICAL BIOMETER HJO NIDEK CO., LTD. AL-SCAN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention