Reported Sep 6, 2017 · Terminated
iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high…
Optovue, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Optovue, Inc. · 2800 Bayview Dr · Fremont, CA · 94538-6518
Is this the product you have?
- iVue with Normative Database, Device Listing Number D185549
- Product UsageThe 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
- Lot codes and dates
Cat No. 700-45575 (GTIN - N/A)700-45575-002 (GTIN - N/A)700-45575-A (GTIN - N/A)700-47818-001 (GTIN - N/A)700-47818-002 (GTIN - N/A)700-47818-003 (GTIN - N/A)700-47818-004 (GTIN 00858848006056)700-47827-002 (GTIN - N/A)700-47827-004 (GTIN - N/A)700-47827-005 (GTIN 00858848006070)700-49007-002 (GTIN - N/A)700-49007-003 (GTIN 00858848006216)
- Amount recalled
- 326 devices
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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