Company:Optovue Inc.
Date of Enforcement Report 5/12//2010
Class:ll

PRODUCT
Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher. 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. Recall # Z-1131-2010

REASON
Marketed without proper 510(k) — No 510(k) clearance for Optovue RTVue Model-RT100 with Software Versions 3.0.x.x and higher which includes the Normative Database.

RECALLING FIRM/MANUFACTURER
Optovue Inc., Fremont, CA, by letter on January 8, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
591 devices

DISTRIBUTION
Nationwide and Internationally