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New Device Approval

Visian ICL™ - P030016

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Visian ICL™ (Implantable Collamer Lens) - Models MICL12.1, MICL12.6, MICL13.2, and MICL 13.7
Applicant: STAAR Surgical Company.
Address: 1911 Walker Avenue, Monrovia, CA 91016
Approval Date: December, 22, 2005
Approval Letter: http://www.fda.gov/cdrh/pdf3/p030016a.pdf

What is it? The Visian ICL™ (Implantable Collamer Lens) is a lens that is permanently implanted in the eye behind the iris and in front of the natural lens. The lens is intended to correct moderate to severe nearsightedness (myopia). This type of lens is called a phakic IOL because the eye still has its natural lens.

How does it work? It works by bending (refracting) light rays to allow them to focus on the retina.

When is it used? The Visian ICL™ is intended for use in healthy eyes, in adults with stable vision. 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 anterior with less than or equal to 2.5D astigmatism at the spectacle plane,
• adults 21-45 years of age with an anterior chamber depth (ACD) of 3.00 mm or greater, and a stable refractive history within 0.5D for 1 year before implantation.

What will it accomplish? The Visian ICL™ may improve a patient’s distance vision without glasses or contact lenses.

In a clinical study of 294 patients implanted with the Visian ICL™, 95 percent had 20/40 or better vision (considered standard vision necessary to obtain a driver's license), and 59 percent had 20/20 or better, after three years.

When should it not be used? The Visian ICL™ should not be used in patients who:

• have an anterior chamber depth less than 3.0 mm as determined by their eye doctor,
• with anterior chamber angle less than Grade II as determined by gonioscopic examination
• are pregnant or nursing, and
• do not meet the minimum endothelial cell density as specified in the labeling.

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf3/p030016.html

Other:
Information on refractive errors: http://www.nlm.nih.gov/medlineplus/refractiveerrors.html

Illustration of the eye: http://www.nei.nih.gov/health/eyediagram/index.asp

Updated January 4, 2006

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