BEUDAMED
    FDA Enforcement Class II Terminated

    OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement and analysis of spherical power, cylindrical power, and cylinder axis.

    Recall: Z-2477-2015 · Reported September 2, 2015

    Enforcement

    Recall Number
    Z-2477-2015
    Event ID
    71691
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nidek Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2015
    Initiation Date
    June 15, 2015
    Classification Date
    August 27, 2015
    Termination Date
    April 25, 2016
    Address
    47651 Westinghouse Dr, N/A, Fremont, CA, 94539-7474, United States

    Description

    OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement and analysis of spherical power, cylindrical power, and cylinder axis.

    Reason

    Software bug was found where there was no difference in Total and Corneal high-order aberrations, but differences were found in Internal high-order aberrations.

    Code Info

    Software versions: 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01.

    Distribution

    Nationwide Distribution.

    Quantity

    3836