BEUDAMED
    FDA Recall Terminated

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    Recall: Z-0024-2013 · Initiated September 7, 2012

    Recall

    Recall Number
    Z-0024-2013
    Event Number
    63211
    Firm
    Optovue Inc.
    FEI Number
    3005950902
    Product Code
    OBO
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    September 7, 2012
    Posted
    October 9, 2012
    Terminated
    March 4, 2013
    Address
    2800 Bayview Dr, Fremont, CA, 94538-6518

    Description

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    Reason

    Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description.

    Action

    Optovue Inc., sent a Voluntary Field Correction and Removal letter dated September 6, 2012, to all affected customers. The letter identified the product the problem and the action to be taken by the customer . Please sign and return the attached form indicating your acknowledgement that that the Affected Materials have been returned or destroyed. If you have any further questions please contact Optovue, at 1-866-344-8948.

    Distribution

    Worldwide Distribution -- USA (nationwide) and Internationally.

    Quantity

    795 units