FDA Device

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

Hazard

A few doctors in the US were inadvertently sent the Cornea Power software version kit for international users instead of the domestic version.

What You Should Do

Remedy

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.

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Products

RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software)
Brand
Optovue Inc.
UPC
Serial numbers: 12797, 12749, 12788, 12790, 12745, 12614, 12771, 11901R1.

Units Affected

8

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