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Important Safety Information

The EVO/EVO+ ICLs are designed for the correction/reduction of myopia in adults ranging from -0.5 D to -20.0 D with less than or equal to 6.0 D of astigmatism at the spectacle plane. The Canada EVO models have a spherical power range of -3.0 D to -18.0 D and cylinder power range of 1.0 D to 6.0 D. The Canada EVO+ models have a spherical power range of -3.0 D to -14.0 D and cylinder power range of 1.0 D to 6.0 D. The hyperopic ICL’s are available in powers ranging from +3.0 to +10.0 diopters for the correction/reduction of hyperopia. The ICLs are indicated for patients who are 21 to 60 years of age. In order to be sure that your surgeon will use a ICL with the most adequate power for your eye, your nearsightedness, farsightedness and astigmatism should be stable for at least a year before undergoing eye surgery. ICL surgery may improve your vision without eyeglasses or contact lenses. ICL surgery does not eliminate the need for reading glasses, even if you have never worn them before. ICL represents an alternative to other refractive surgeries including, laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), incisional surgeries, or other means to correct your vision such as contact lenses and eye glasses. Implantation of an ICL is a surgical procedure, and as such, carries potentially serious risks. The following represent potential complications/adverse reactions reported in conjunction with refractive surgery in general: additional surgeries, cataract formation, loss of best corrected vision, raised pressure inside the eye, loss of cells on the innermost surface of the cornea, conjunctival irritation, acute corneal swelling, persistent corneal swelling, endophthalmitis (total eye infection), significant glare and/or halos around lights, hyphaema (blood in the eye), hypopyon (pus in the eye), eye infection, ICL dislocation, macular oedema, non-reactive pupil, pupillary block glaucoma, severe inflammation of the eye, iritis, uveitis, vitreous loss and corneal transplant. Before considering ICL surgery you should have a complete eye examination and talk with your eye care professional about ICL surgery, especially the potential benefits, risks, and complications. You should discuss the time needed for healing after surgery.