BEUDAMED
    FDA Recall 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 · Initiated June 15, 2015

    Recall

    Recall Number
    Z-2477-2015
    Event Number
    71691
    Firm
    Nidek Inc
    FEI Number
    2936921
    Product Code
    HKO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 15, 2015
    Posted
    August 27, 2015
    Terminated
    April 25, 2016
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474

    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.

    Action

    Dear Doctor letters mailing started on July 15, 2015 - first 100. They will be mailed out as the correction is received from Nidek, Japan. Dear Doctor letter will include software upgrade kit including CD or USB, instruction for upgrade and pre-paid response card to be returned to Nidek Inc.

    Distribution

    Nationwide Distribution.

    Quantity

    3836