iVue 500 with iScan — Class II medical device recall Z-0010-2018
Terminated recall by Optovue, Inc., reported 2017-09-06, distributed nationwide. FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
| Recall number | Z-0010-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Optovue, Inc., Fremont, CA, United States |
| Recall initiated | 2017-07-27 |
| Classified | 2017-10-04 |
| Reported by FDA | 2017-09-06 |
| Terminated | 2021-04-12 |
| Distributed | Nationwide (US) |
| Quantity | 326 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00858848006018, 00858848006315 |
| Model numbers | 700-49428-001 |
Product
iVue 500 with iScan, D216606. Product 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 500 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 500 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 for recall
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0010-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.