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U.S. Department of Health and Human Services

Class 2 Device Recall Optovue RTVue, iVue

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 Class 2 Device Recall Optovue RTVue, iVuesee related information
Date Initiated by FirmSeptember 07, 2012
Date PostedOctober 09, 2012
Recall Status1 Terminated 3 on March 04, 2013
Recall NumberZ-0024-2013
Recall Event ID 63211
510(K)NumberK091404 K101505 
Product Classification Tomography optical coherence - Product Code OBO
ProductReference 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.
Code Information All units of these models.
Recalling Firm/
Manufacturer		 Optovue Inc.
2800 Bayview Dr
Fremont CA 94538-6518
For Additional Information ContactAzimun Jamal
510-623-8868 Ext. 102
Manufacturer 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.
FDA Determined
Cause 2		No Marketing Application
ActionOptovue 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.
Quantity in Commerce795 units
DistributionWorldwide Distribution -- USA (nationwide) and Internationally.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OBO
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