Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Optovue iVue with Normative Database (NDB) with Software Version 3.0 Recalled by Optovue, Inc. Due to Colors from the NDB comparison for Ganglion Cell...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Optovue, Inc. directly.
Affected Products
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Quantity: ~329 users
Why Was This Recalled?
Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Optovue, Inc.
Optovue, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report