Recall Z-0024-2013— Optovue Inc.

Name: FDA recall Z-0024-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-07

Class II · Terminated

Class II FDA medical device recall by Optovue Inc., initiated 2012-09-07, terminated 2013-03-04. It names 2 FDA 510(k) clearances: K101505, K091404. Product: Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product 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.. Reason: Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description..

Recalling firm: Optovue Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-09-07
Terminated: 2013-03-04
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K101505 — RTVUE MODEL RTVUE 100Optovue, Inc.·cleared 2010-09-15
K091404 — IVUE, MODEL 100Optovue, Inc.·cleared 2010-04-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product 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.

Reason for recall

Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description.

Data sourced from openFDA. This site is unofficial and independent of the FDA.