Optovue, Inc. recalls iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging devic…

Recall date

July 27, 2017

Source

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

Recall number

Z-0009-2018

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

iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, 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 with Normative Database is a quantitative tool for comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.