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U.S. Department of Health and Human Services

Class 2 Device Recall Optovue iVue

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  Class 2 Device Recall Optovue iVue see related information
Date Initiated by Firm July 20, 2010
Date Posted February 01, 2011
Recall Status1 Terminated 3 on February 08, 2011
Recall Number Z-1004-2011
Recall Event ID 56759
510(K)Number K091404  
Product Classification System, imaging, optical coherence tomography (oct) - Product Code NQQ
Product Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA
Computer controlled opthalmic imaging system. Device scans the patient's eye using low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface. The computer has a graphic user interface for acquiring and analyzing the image. The iVue offers three scans: Retina, Glaucoma and Cornea. For the cornea scan, a lens must be attached to the front of the device for proper scanning. This is the Cornea Anterior Module (CAM).
Code Information Serial numbers: 20305, 20307, 20340, 20335, 20306, 20313, 20339, 20337, 20338, 20341, 20311, 20271, 20343, 20312, 20309, 20310, 20308, 20336, 20344, 20349, 20346, 20347
Recalling Firm/
Optovue Inc.
45531 Northport Loop W
Fremont CA 94538-6417
For Additional Information Contact Paul Kealey
510-623-8868 Ext. 102
Manufacturer Reason
for Recall
Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient.
FDA Determined
Cause 2
Software design (manufacturing process)
Action Optovue Inc. sent a Field Modification/Correction Notice dated July 20, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were informed that they could continue to use the iVue until the correction has been made. Customers were instructed to review any existing iVue patient data to ensure that this situation and an improper designation of eye assignment has not occurred. Upon completion of the updates, customers were to sign the attached form indicating they acknowledge that their iVue has been updated and they understand that they must review existing data. For any questions regarding this recall call 1-866-344-8948 or by mail at 45531 Northport Loop W, Fremont, CA 94538.
Quantity in Commerce 22 devices in the US.
Distribution Nationwide
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = NQQ and Original Applicant = OPTOVUE, INC.