Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
iVue with Normative Database Recalled by Optovue, Inc. Due to FDA determined that a 510(k) is needed for...
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
iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Quantity: 326 devices
Why Was This Recalled?
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
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