FDA Device recall Z-0008-2018
iVue with Normative Database, Device Listing Number D185549
- FDA Device
- Class II
- terminated
- Published 2017-09-06
On 2017-09-06 the FDA classified a Class II recall of iVue with Normative Database, Device Listing Number D185549 by Optovue, citing FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0008-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-27 |
| Published | 2017-09-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Optovue |
| Distribution | US |
Product
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.
Reason
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Identifiers
| code_info | 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), 700-4…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). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0008-2018%22
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