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Important Safety Information – Verisyse® Phakic IOL

Verisyse® intraocular lenses are indicated for the reduction or elimination of myopia in adults with myopia ranging from -5.0 to -20.0 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane and whose eyes have an anterior chamber depth greater than or equal to 3.2 millimeters; and, patients with documented stability of refraction for the prior 6 months, as demonstrated by spherical equivalent change of less than or equal to 0.50 diopters.

Implantation of a Verisyse® IOL is a surgical procedure, and as such, carries potentially serious risks. Please review the patient information brochure for this IOl and discuss the risks with your doctor. If your results with a Verisyse® IOL are not satisfactory, there may be a need for an additional surgical procedure to adjust the lens, exchange the lens or remove the lens. The Verisyse® IOL doe not eliminate the need for reading glasses. In some cases, you may need reading glasses after implantation of the Verisyse® IOl even if you did not need them before.

You should not receive a Verisyse® IOL is you are less than 18 years of age, you have more than 2 diopters of astigmatism, or you have an abnormal iris, pupil or cornea.

If you have any of the following conditions, be sure to discuss them with your doctor:

The safety and effectiveness of the Verisyse® IOL for correction of nearsightedness have NOT been established in patients. Therefore, your physician should continue to monitor your vision regularly. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who receive lens implants. The intraocular pressure of patients with glaucoma should be monitored postoperatively. The effectiveness of ultraviolet light absorbing lenses in reducing the incidence of retinal disorders has not been established.

Adverse Events:
The most frequently reported adverse event that occurred during the clinical trial of the Verisyse® lens was secondary surgical intervention (including lens exchange, lens removal, lens reattachment/repositioning, retinal repair, YAG, LASIK, re-suture, aqueous release, AK, LRI, punctal plugs inserted, and PRK) which occurred at a rate of 13.6%.