Events

Recall of Device Recall Optovue iVue and iVue 500

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
    73612
  • Event Risk Class
    Class 2
  • Event Number
    Z-1498-2016
  • Event Initiated Date
    2016-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144628
  • 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
    A software anomaly was detected that affects optovue ivue and ivue 500 with normative database that may display images of the same eye rather than right and left if user scrolls on the map.
  • Action
    Recall Letters were sent to customers on March 22, 2016 to inform them of the recall.

Device

Device Recall Optovue iVue and iVue 500
  • Model / Serial
    US and foreign (not yet provided) Software version 2016.0.0.127: Serial numbers:  21908, 26507, 26496, 26558, 22738, 26139, 26442, 25720, 25079, 25142, 23298, 21990, 23461, 24199, 25843, 26572, 26550, 22971, 26495, 22652, 26550, 22971, 26495, 22652, 25389, 23309, 23760, 21732-1, 23527, 20923, 21600, 21414, 20271, 23153, 22875, 23211. Software version 2016.1.0.127; Serial numbers forthcoming.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    PA, CA, IL, HI. MO, CO, GA, ME, IN, AZ, WV, VA, FL, AR, UT, NE, IN, NV, LA, TN, KS, OK. Foreign distribution forthcoming
  • Product Description
    iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) || Opthalmic: iVue is a 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 the eye.
  • 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