Device Recall Optovue RTVue Optical Coherence Tomography with Normative Database

Serial Numbers from 10005 to 11805 (serial number are sequential)

Ophthalmic Devices

2

No

Nationwide and Worldwide

Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher, with Normative Database, manufactured by Optovue, Fremont, CA || The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.