Recall Z-1498-2016— Optovue, Inc.

Name: FDA recall Z-1498-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-16

Class II · Terminated

Class II FDA medical device recall by Optovue, Inc., initiated 2016-03-16, terminated 2017-04-04. It names 2 FDA 510(k) clearances: K133892, K121739. Product: 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.. 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..

Recalling firm: Optovue, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-03-16
Terminated: 2017-04-04
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K133892 — IVUE 500Optovue, Inc.·cleared 2014-03-19
K121739 — IVUE WITH NORMATIVE DATABASEOptovue, Inc.·cleared 2013-01-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.