BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPD-SCAN III

    MDR report key: 7793853 · Received August 17, 2018

    Report

    Report Number
    0002936921-2018-00009
    Event Type
    Injury
    Date Received
    August 17, 2018
    Date of Event
    June 18, 2018
    Report Date
    February 19, 2019
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    HKO
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS INSPECTED BY MARCO (NIDEK'S DISTRIBUTOR) FSE AND NO PROBLEM WAS FOUND DURING INSPECTION. IN ADDITION, THE OPERATOR OF THE DEVICE CONFIRMED THAT THE DEVICE HAS BEEN WORKING PROPERLY. THE DEVICE COMPLIES WITH INTERNATIONAL STANDARDS (IEC15004-2:2007) REGARDING THE SAFETY OF LIGHT EMISSION FOR THE EYE OPTICAL DEVICE. THE FLASH LIGHT WAS PREMISSIBLE FOR HUMAN EYE AS PER THE STANDARDS. NIDEK JAPAN (DEVICE MANUFACTURER) REVIEWED THE DEVICE HISTORY RECORD THAT ALL ITEMS MET THE REQUIRED QUALITY CRITERIA AT THE FINAL INSPECTION. THERE WERE NO SIMILAR COMPLAINTS AND/OR OVER EMISSION ISSUE OBSERVED IN THE PAST.

    Description of Event or Problem · 0

    PLEASE REFER INITIAL MDR SUBMITTED ON 08/17/2018 FOR DETAILS.

    Additional Manufacturer Narrative · 1

    NIDEK INC. CONSIDERS THIS A REPORTABLE EVENT, HOWEVER DEVICE MALFUNCTION IS YET TO BE DETERMINED. AT THIS TIME, NIDEK HAS NO ADDITIONAL INFORMATION OF PATIENT CONDITION AND EVALUATION ON THE DEVICE HAS NOT BEGUN, A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE DEVICE EVALUATION AND REPAIR ARE COMPLETED.

    Description of Event or Problem · 1

    ON AUGUST 3, 2018, NIDEK INC. SENIOR RA/QA MANAGER RECEIVED AN EMAIL FROM OUR DISTRIBUTOR (B)(4) DIRECTOR OF CUSTOMER CARE REGARDING A COMPLAINT THEY RECEIVED ON JUNE 22, 2018 FROM THEIR CUSTOMER, (B)(6). A PATIENT ((B)(6)) AT (B)(6) HAD AN EYE EXAM, AND EXPERIENCED A VERY BRIGHT FLASH FROM OPD AND FELT LIKE THERE WAS A REACTION AND HER (OPTICAL) NERVES OR SOMETHING MAY HAVE BEEN AFFECTED. (B)(6) COMPLAINED THAT NO ONE WARNED HER ABOUT THE LIGHT AND THAT SHE TOLD THEM NOT TO TAKE ANY PICTURES INCLUDING OPD CT IMAGES, SO THE IMAGES WERE NOT PERMITTED BY HER. THE DOCTOR PERFORMING THE PROCEDURE, HOWEVER, EXPLAINED THE ENTIRE PROCEDURE INCLUDING THE TECHNOLOGY AND THE SOFTWARE TO BE USED AND AFFIRMED THAT THEY WERE SAFE FOR USE. HOWEVER, THE PATIENT WAS VERY UPSET AND CLAIMED THAT THE DOCTOR WAS DEFENDING THE EQUIPMENT DESPITE ACKNOWLEDGING HAVING UNDERSTOOD AND RECEIVING ALL THE INFORMATION PRIOR TO THE EXAMINATION. THE PATIENT ADDED THAT SHE WAS EXPERIENCING SYMPTOMS OF EYESTRAIN, SENSITIVITY TO LIGHT AND ANXIETY. THE PATIENT HAS GONE TO HER VISION PLAN TO COMPLAIN, BUT WAS TOLD NOTHING WAS DONE WRONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635521 OPD-SCAN III OPD-SCAN III REFRACTIVE POWER/CORNEAL ANALYZER HKO NIDEK CO. LTD. OPD-SCAN III N/A

    Patients

    Seq Age Sex Outcome Treatment
    1