Events

Recall of Device Recall Optical Coherence Tomography System

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
    77776
  • Event Risk Class
    Class 2
  • Event Number
    Z-0010-2018
  • Event Initiated Date
    2017-07-27
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157860
  • 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
    Fda determined that a 510(k) is needed for the vault mapping software (also known as lens fitting).
  • Action
    Optovue sent an Urgent Medical Device Software Field Correction letter dated July 27, 2017, via FedEx mail. Customers were Instructed to discontinue use of the Vault Mapping software, to complete and return the recall response form, and to provide remote access to units to an Optovue representative so that new software can be downloaded remotely. Questions can be addressed by calling Optovue at 1-866-941-9240.

Device

Device Recall Optical Coherence Tomography System
  • Model / Serial
    Cat No. 700-49428-001 (GTIN - N/A), 700-49428-002 (GTIN 00858848006315), 700-49428-003 (GTIN 00858848006018).
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV.
  • Product Description
    iVue 500 with iScan, D216606. || Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, || documentation, and management of ocular health and diseases in the adult population.
  • 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