Staar Surgical's myopia lens implanted in first U.S. patient

By Angela McDaniels

Seattle, Jan. 11 - Staar Surgical Co. said the first Visian ICL (Implantable Collamer Lens) has been surgically implanted in the United States. The Food and Drug Administration approved the premarket approval application for the lens in December.

John Vukich of the Davis Duehr Dean Medical Center in Madison, Wis., performed the procedure.

"[The patient] showed significant improvement instantaneously and, within one hour following the procedure, was able to see better than 20/20 without eyeglasses," Vukich said in a company news release.

"The Visian ICL is an exciting technological advancement and it will allow a great number of individuals suffering from nearsightedness to enjoy clear vision without glasses. The ICL has been shown to be a safe, minimally invasive procedure that has produced outstanding clinical outcomes."

Staar said the Visian ICL is the only foldable, minimally invasive lens approved for the correction of myopia, or nearsightedness, in adults. It is implanted during a reversible, six-minute procedure through a micro incision to allow positioning of the implant behind the iris, or the colored part of the eye.

The ICL is made of a biocompatible Collamer material that contains a small amount of collagen, and its unique lens design allows it to be implanted through an incision 50% smaller than competing technology, according to the release.

Currently, more than 860 surgeons in the United States have completed the first phase of training toward becoming certified to conduct the procedure. Staar said that doctors familiar with the technology have noted the ICL's stability, the safety of the procedure, superior clinical outcomes and high patient satisfaction rate.

In addition to the United States, the ICL is approved for sale in 41 countries and has been successfully implanted in more than 40,000 eyes worldwide, the company said.

Staar Surgical is based in Monrovia, Calif., and develops, manufactures and markets minimally invasive ophthalmic products using proprietary technologies.

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