Class II — Optovue Inc.
| Recalling firm | OPTOVUE, INC. |
|---|---|
| Registered facility | OPTOVUE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description. |
| Product | Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease. |
| Quantity | 795 units |
| Distribution | Worldwide Distribution -- USA (nationwide) and Internationally. |
| Initiated | 2012-09-07 |
| Classified | 2012-10-22 |
| Terminated | 2013-03-04 |
| Recall number | Z-0024-2013 |
| 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-0024-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63211/
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