Class III — Optovue, Inc.
| Recalling firm | OPTOVUE, INC. |
|---|---|
| Registered facility | OPTOVUE, INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports. |
| Product | Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging. |
| Quantity | ~329 users |
| Distribution | Distributed Nationwide and in Canada. |
| Initiated | 2013-05-14 |
| Classified | 2013-05-31 |
| Terminated | 2013-10-24 |
| Recall number | Z-1441-2013 |
| 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 III recall — Optovue, Inc. (Z-1441-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65191/
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