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Optovue, Inc. recalls iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in
Recalled September 6, 2017 · FDA recall Z-0010-2018 · Optovue
Hazard
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). · FDA Class II
Units
326 devices
Sold at
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.
Description
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Product
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.
Manufacturer(s)
Optovue, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →