Class II — Optovue, Inc.
| Recalling firm | OPTOVUE, INC. |
|---|---|
| Registered facility | OPTOVUE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). |
| 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… |
| Quantity | 326 devices |
| Distribution | US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV. |
| Initiated | 2017-07-27 |
| Classified | 2017-10-04 |
| Terminated | 2021-04-12 |
| Recall number | Z-0010-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Optovue, Inc. (Z-0010-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77776/
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