Reference materials "RETINAL OCT Analysis and Interpretation Method"… — Class II medical device recall Z-0024-2013
Terminated recall by Optovue Inc., reported 2012-10-31, distributed nationwide. Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" pos
| Recall number | Z-0024-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Optovue Inc., Fremont, CA, United States |
| Recall initiated | 2012-09-07 |
| Classified | 2012-10-22 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2013-03-04 |
| Distributed | Nationwide (US) |
| Quantity | 795 units |
| Reason classes | labeling |
| Model numbers | IVUE-100, RTVUE-100 |
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.
Reason for recall
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.
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-0024-2013. 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.