Optovue, Inc. recalls iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vi…

Recall date

July 27, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0010-2018

FDA classification

Class II

Brand / firm

Optovue, Inc.

Sold / distributed

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.

Why it was recalled

FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.