Device Recall Optovue iVue and iVue 500

US and foreign (not yet provided) Software version 2016.0.0.127: Serial numbers:  21908, 26507, 26496, 26558, 22738, 26139, 26442, 25720, 25079, 25142, 23298, 21990, 23461, 24199, 25843, 26572, 26550, 22971, 26495, 22652, 26550, 22971, 26495, 22652, 25389, 23309, 23760, 21732-1, 23527, 20923, 21600, 21414, 20271, 23153, 22875, 23211. Software version 2016.1.0.127; Serial numbers forthcoming.

Ophthalmic Devices

2

No

PA, CA, IL, HI. MO, CO, GA, ME, IN, AZ, WV, VA, FL, AR, UT, NE, IN, NV, LA, TN, KS, OK. Foreign distribution forthcoming

iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) || Opthalmic: iVue is a 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 the eye.