iFusion — Class II medical device recall Z-0009-2018
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-0009-2018 |
|---|---|
| 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 | 00858848006186 |
| Model numbers | 700-49001-001 |
Product
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, 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 comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.
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-0009-2018. 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.