FDA-Device2013-06-05Class II
Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
Canon Inc.
Hazard
Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probability.
Sold states
Worldwide Distribution - USA Nationwide and countries of: Australia, Japan, Korea, Singapore and United Kingdom.
Affected count
384 units
Manufactured in
30-2, Shimomaruko 3-chome,, Ohta-ku, Tokyo, N/A, Japan
Products
Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1404-2013Don't want to check this manually?
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