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.
FDA Recall Z-0024-2013 · Posted 2012-10-09
Advertisement
Recalling FirmOptovue Inc.
Recall StatusTerminated
Product CodeOBO
Date Initiated2012-09-07
Date Terminated2013-03-04
Product Quantity795 units
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.
Firm Action
Optovue Inc., sent a Voluntary Field Correction and Removal letter dated September 6, 2012, to all affected customers. The letter identified the product the problem and the action to be taken by the customer .
Please sign and return the attached form indicating your acknowledgement that that the Affected Materials have been returned or destroyed.
If you have any further questions please contact Optovue, at 1-866-344-8948.
Root Cause
No Marketing Application
Distribution Pattern
Worldwide Distribution -- USA (nationwide) and Internationally.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement