BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AL-SCAN

    MDR report key: 8015938 · Received October 29, 2018

    Report

    Report Number
    0002936921-2018-00010
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    August 20, 2018
    Report Date
    December 12, 2018
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    HJO
    PMA / PMN Number
    K133132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE AL-SCAN DEVICE S/N 220002 WAS EVALUATED BY NIDEK INC. IN-HOUSE SERVICE ENGINEER (SE). THE CUSTOMER REPORTED ISSUE OF AUTO FOCUS FUNCTION NOT WORKING AND THE K READING NOT SHOWING UP ON THE DEVICE COULD NOT BE CONFIRMED. THE DEVICE FUNCTIONED PROPERLY, NO PROBLEM FOUND DURING TESTS AND INSPECTIONS BY A NIDEK INC. SERVICE ENGINEER (SE). THE DEVICE WAS TESTED FROM 10/17/2018 THROUGH 12/06/2018 WITH AN AL MODEL EYE UNIT AND CONFIRMED THAT THE MEASURED VALUES ARE WITHIN THE RANGE INDICATED ON THE MODEL EYE: AL=28.00+/-0.05(MM) AND KM=8.01+/-0.02(MM). NIDEK INC. DETERMINED THAT THERE WAS NO MALFUNCTION IN THE AL-SCAN DEVICE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER AND HENCE IT COULD NOT BE CONFIRMED THAT THE DATA MEASUREMENTS USED FOR LENS CALCULATION WERE PERFORMED BY NIDEK PRODUCT OR OTHER MANUFACTURER'S DEVICE. NIDEK INC PROVIDES IN-SERVICE TRAINING ON THE PRODUCTS TO THE CUSTOMERS AND SUCH TRAINING WAS PROVIDED TO THIS CUSTOMER ON 4/16/2018. PLEASE REFER TO THE ATTACHED IN-SERVICE TRAINING RECORD.

    Description of Event or Problem · 0

    PLEASE REFER TO THE INITIAL MDR SUBMITTED ON 29-OCT-2018 FOR DETAILS.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DEVICE AND INVESTIGATION OF THE ISSUE IS ON-GOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE EVALUATION OF THE DEVICE IS FULLY COMPLETED. (B)(4) DETERMINED THAT THIS IS A REPORTABLE EVENT AS WE BECAME AWARE OF A MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. SEE ATTACHED CUSTOMER COMMUNICATION EMAILS AS WELL AS PARAMETER MEASUREMENTS FOR REFERENCES.

    Description of Event or Problem · 1

    (B)(4) RECEIVED AN E-MAIL NOTIFICATION ON (B)(6) 2018 ADDRESSED TO THE TERRITORY SALES MANAGER THAT THE CUSTOMER (DOCTOR) HAD PERFORMED THREE LENS EXCHANGES OWING TO THE SIGNIFICANTLY WRONG LENS CALCULATIONS MADE BY THE AL-SCAN DEVICE SERIAL (B)(4). HOWEVER, IT WAS LATER CONFIRMED BY THE CUSTOMER THAT THERE WERE ONLY TWO LENS EXCHANGES PERFORMED. THE PATIENTS HAD COMPLAINED OF VERY POOR VISUAL ACUITY POST OPERATIVELY FOLLOWING THE INITIAL PROCEDURES. THE TYPE OF IOL USED WAS SN60WF MANUFACTURED BY ALCON. IN ADDITION, ON (B)(6) 2018 THE CUSTOMER ADDED EXPERIENCING ISSUES WITH AUTO FOCUS FUNCTION AND THE K READING NOT SHOWING UP ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853556 AL-SCAN OPTICAL BIOMETER HJO NIDEK CO. LTD. AL-SCAN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention