Events

Recall of Device Recall Optovue iVue with Normative Database

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
    65191
  • Event Risk Class
    Class 3
  • Event Number
    Z-1441-2013
  • Event Initiated Date
    2013-05-14
  • Event Date Posted
    2013-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118193
  • 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
    Ophthalmoscope, ac-powered - Product Code HLI
  • Reason
    Colors from the ndb comparison for ganglion cell complex thickness in the singular ou report in ivue version 3.0 (us) and 3.1(international) are different from those in the individual iwellness id and os reports.
  • Action
    Optovue sent a Field Correction Notice letter dated May 16, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

Device

Device Recall Optovue iVue with Normative Database
  • Model / Serial
    iVue software version 3.0 and 3.1 3.1 is international version, only distributed to Canada but not currently installed in any Canadian facilities.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed Nationwide and in Canada.
  • Product Description
    Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. || Intended for in vivo imaging.
  • 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