Events

Recall of Optovue RTVue, iVue

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Optovue Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63211
  • Event Risk Class
    Class 2
  • Event Number
    Z-0024-2013
  • Event Initiated Date
    2012-09-07
  • Event Date Posted
    2012-10-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113022
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tomography optical coherence - Product Code OBO
  • 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.

Device

Optovue RTVue, iVue
  • Model / Serial
    All units of these models.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and Internationally.
  • Product 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.
  • Manufacturer
    Optovue Inc.

Manufacturer

Optovue Inc.
  • Manufacturer Address
    Optovue Inc., 2800 Bayview Dr, Fremont CA 94538-6518
  • Manufacturer Parent Company (2017)
    Optovue Inc.
  • Source
    USFDA