BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCANMATE A

    MDR report key: 6281074 · Received January 26, 2017

    Report

    Report Number
    2522950-2017-00001
    Event Type
    Injury
    Date Received
    January 26, 2017
    Report Date
    December 26, 2016
    Manufacturer
    DGH TECHNOLOGY, INC.
    Product Code
    IYO
    UDI-DI
    00857377006094
    PMA / PMN Number
    K093371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THUS FAR, LITTLE INFORMATION HAS BEEN PROVIDED BY THE USER RELATED TO THE EVENT. REQUESTS FOR ADDITIONAL INFORMATION HAVE YET TO BE FULFILLED. FROM THE INFORMATION PROVIDED, IT APPEARS THAT THE PROBE MAY HAVE BEEN APPLIED OFF-AXIS TO THE EYE (INCORRECT MANUAL APPLANATION BY THE USER), RESULTING IN AN INCORRECT AXIAL LENGTH MEASUREMENT. HOWEVER IT IS NOT POSSIBLE TO CONCLUSIVELY DETERMINE THIS WITHOUT ADDITIONAL INFORMATION BY THE USER. THE DISTRIBUTOR ((B)(4)) HAS ARRANGED TO FOLLOW UP WITH USER (DR. (B)(6)) IN FEBRUARY (16TH-19TH). DEVICE PRODUCTION HISTORY FOR UNIT 2016-0387 HAS BEEN REVIEWED. NO PRODUCTION/QUALITY CONTROL ISSUES WERE IDENTIFIED. DEVICE LABELING (USER INSTRUCTIONS) IS UNDER REVIEW FOR EFFICACY AND CLARITY.

    Description of Event or Problem · 1

    A DISTRIBUTOR ((B)(4)) STATED THAT A USER (DR. (B)(6)) ALLEGED HIS DEVICE WAS NOT GIVING A PROPER READING WHEN PERFORMING MEASUREMENTS. WHEN CONTACTED FOR ADDITIONAL INFORMATION, DR. (B)(6) STATED THAT USING MEASUREMENTS TAKEN WITH THE DEVICE (FOR IOL CALCULATIONS) YIELDED A REFRACTIVE ERROR OF -3.00, -3.50 AND -2.50 DIOPTERS, WHICH WAS GREATER THAN THE DESIRED RESULT. DATES OF EVENT UNKNOWN. THE DOCTOR STATED THAT RAYNER INTRAOCULAR LENSES WERE USED (POWER AND MODEL UNKNOWN). PATIENT INFORMATION WAS NOT GIVEN, HOWEVER FROM THE DESCRIPTION PROVIDED IT APPEARS THAT PATIENTS EXPERIENCED THIS LEVEL OF REFRACTIVE ERROR FOLLOWING SURGERY. NECESSITY OF ADDITIONAL MEDICAL/SURGICAL INTERVENTION UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63985 SCANMATE A OPHTHALMIC A-SCAN IYO DGH TECHNOLOGY, INC. DGH 6000 00857377006094

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other APPASAMY KERATOMETER