Z-0024-2013Class II

Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and...

Name: Z-0024-2013 Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and...
Creator: Optovue Inc.
Published: 2012-09-07
License: https://open.fda.gov/license/

Optovue Inc. / initiated 2012-09-07 / Terminated / root cause: labeling and UDI

FDA source

Optovue Inc. began a recall of Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System... on 2012-09-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0024-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-07
Posted: 2012-10-09
Terminated: 2013-03-04
Recalling firm: Optovue Inc.
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.
Product code: OBO Tomography, Optical Coherence
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.
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
Action: Optovue Inc., sent a Voluntary Field Correction and Removal letter dated September 6, 2012, to all affected customers. The letter identified the product the problem and the action to be taken by the customer . Please sign and return the attached form indicating your acknowledgement that that the Affected Materials have been returned or destroyed. If you have any further questions please contact Optovue, at 1-866-344-8948.
Quantity in commerce: 795 units
Distribution: Worldwide Distribution -- USA (nationwide) and Internationally.
Product codes and lots: All units of these models.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0024-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0024-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-22

Product code OBO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)