Z-1004-2011

Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured...

Name: Z-1004-2011 Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured...
Creator: Optovue Inc.
Published: 2010-07-20
License: https://open.fda.gov/license/

Optovue Inc. / initiated 2010-07-20 / Terminated / root cause: software

FDA source

Optovue Inc. began a recall of Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA Computer controlled... on 2010-07-20. The reason FDA records is "Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1004-2011
Status: Terminated
Initiated: 2010-07-20
Posted: 2011-02-01
Terminated: 2011-02-08
Recalling firm: Optovue Inc.
Product: Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA Computer controlled opthalmic imaging system. Device scans the patient's eye using low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface. The computer has a graphic user interface for acquiring and analyzing the image. The iVue offers three scans: Retina, Glaucoma and Cornea. For the cornea scan, a lens must be attached to the front of the device for proper scanning. This is the Cornea Anterior Module (CAM).
Product code: NQQ System, Imaging, Optical Coherence Tomography (Oct)
Reason for recall: Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Optovue Inc. sent a Field Modification/Correction Notice dated July 20, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were informed that they could continue to use the iVue until the correction has been made. Customers were instructed to review any existing iVue patient data to ensure that this situation and an improper designation of eye assignment has not occurred. Upon completion of the updates, customers were to sign the attached form indicating they acknowledge that their iVue has been updated and they understand that they must review existing data. For any questions regarding this recall call 1-866-344-8948 or by mail at 45531 Northport Loop W, Fremont, CA 94538.
Quantity in commerce: 22 devices in the US.
Distribution: Nationwide
Product codes and lots: Serial numbers: 20305, 20307, 20340, 20335, 20306, 20313, 20339, 20337, 20338, 20341, 20311, 20271, 20343, 20312, 20309, 20310, 20308, 20336, 20344, 20349, 20346, 20347

Product code NQQ

K091404Class IIIvue, Model 100Optovue, Inc. / cleared 2010-04-22

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)