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

Recalled September 6, 2017 · FDA recall Z-0009-2018 · 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

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.

Manufacturer(s)

Optovue, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →