Optovue Inc.: Medical Device Recalls in 2012

Updated on March 25, 2026.

According to to data from the FDA, there was 1 medical device recall made by Optovue Inc. in 2012. See the detail of the recall below.

You can see similar recalls for other firms.

Data Source: FDA.

See this for other years:

Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.