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What are the U.S. FDA indications for the ICL?

The Visian ICL™ was U.S. FDA approved in December 2005. It is intended for use in adults with healthy eyes and stable spectacle and / or contact lens prescriptions. It is designed for:

· The correction of myopia ranging from -3 to -15 diopters (D) with less than or equal to 2.5D of astigmatism at the spectacle plane 
· The reduction of myopia ranging from -15D to -20D with less than or equal to 2.5D astigmatism at the spectacle plane
· Adults 21 years of age or older with a stable refractive history within 0.5D for 1 year before implantation

A toric version of the Visian ICL™ for patients with myopia and astigmatism has completed US FDA trials and is under review; results are very promising!

The Visian ICL™ is not approved for patients with hyperopia in the U.S.