FDA Medical Device Recalls (openFDA)
Optovue Inc.: RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software)
- Recall number
- Z-1340-2012
- Recalling firm
- Optovue Inc.
- Product
- RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software)
- Status
- Terminated
- Initiated
- 2012-02-21
- Posted
- 2012-03-30
- Terminated
- 2012-04-02
- Reason
- 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
- 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
- 8
- Distribution
- Nationwide Distribution -- CA and WA only
- Lot, serial or model codes
- Serial numbers: 12797, 12749, 12788, 12790, 12745, 12614, 12771, 11901R1.
- 510(k) numbers
- ["K111505"]
- PMA numbers
- not on file
- Product code
- OBO
- Firm FEI
- 3005950902
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28