Optovue, Inc.: Medical Device Recalls in 2016

Updated on March 25, 2026.

According to to data from the FDA, there was 1 medical device recall made by Optovue, Inc. in 2016. See the detail of the recall below.

You can see similar recalls for other firms.

Data Source: FDA.

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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.