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New Device Approval

Verisyse™ Phakic IOL - P030028

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: Verisyse™ (Model VRSM5US and VRSM6US) also known as ARTISAN® (Model 206 and 204) Phakic Intraocular Lens (IOL)
Applicant: Ophtec USA Inc.
Address: 6421 Congress Avenue - Suite 112, Boca Raton, FL 33487
Approval Date: September 10, 2004
Approval Letter: http://www.fda.gov/cdrh/pdf3/p030028a.pdf

What is it? The Verisyse™ phakic intraocular lens (IOL) is a plastic lens that is permanently implanted in the eye and attached to the iris to correct moderate to severe nearsightedness (myopia). It is called a phakic IOL because the eye still has its natural lens.

How does it work? The Verisyse™ is implanted in front of the natural lens of the eye. It works by bending (refracting) light rays to allow them to focus on the retina.

When is it used? The Verisyse™ is intended for use in healthy eyes, in people with stable vision. The lens is used to reduce or eliminate myopia in adult patients who have:

• myopia ranging from -5 to -20 diopters with less than or equal to 2.5 diopter of astigmatism at the spectacle plane,
• an anterior chamber depth greater than or equal to 3.2 millimeters, and
• stable refraction (less than 0.5 diopters change for 6 months) as determined by their eye doctor.

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

In a clinical study of 662 patients implanted with the Verisyse™, 92 percent had 20/40 or better vision (considered standard vision necessary to obtain a driver's license), and 44 percent had 20/20 or better, after three years.

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

• are less than 21 years,
• have an anterior chamber depth less than 3.2 mm as determined by their eye doctor,
• have an abnormal iris or cornea,
• 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/p030028.html

Other:

• FDA Talk Paper: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01313.html
• 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 October 28, 2004

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