Z-1340-2012

RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software)

Name: Z-1340-2012 RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software)
Creator: Optovue Inc.
Published: 2012-02-21
License: https://open.fda.gov/license/

Optovue Inc. / initiated 2012-02-21 / Terminated / root cause: manufacturing process

FDA source

Optovue Inc. began a recall of RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software) on 2012-02-21. The reason FDA records is "A few doctors in the US were inadvertently sent the Cornea Power software version kit for international users instead of the domestic version". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1340-2012
Status: Terminated
Initiated: 2012-02-21
Posted: 2012-03-30
Terminated: 2012-04-02
Recalling firm: Optovue Inc.
Product: RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software)
Product code: OBO Tomography, Optical Coherence
Reason for recall: A few doctors in the US were inadvertently sent the Cornea Power software version kit for international users instead of the domestic version.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Field Correction letters were sent to all doctors affected by the issue on February 23, 2012. The letter identified the affected product and the problem. The letter also stated that customers may continue to use the RTVue until the correction was made. Once the correction has been made, customers are to sign and return the attached acknowledgement form. If customers had questions, they are to contact Optovue at 1-866-344-8948 or via mail at 45531 Northport Loop W, Fremont, CA 94538.
Quantity in commerce: 8
Distribution: Nationwide Distribution -- CA and WA only
Product codes and lots: Serial numbers: 12797, 12749, 12788, 12790, 12745, 12614, 12771, 11901R1.

Product code OBO

K111505Class IIRtvue Cam with Corneal Power UpgradeOptovue, Inc. / cleared 2011-09-08

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)