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Important Safety Information

IMPORTANT SAFETY INFORMATION FOR THE VISIAN ICL PRODUCT FAMILY:

The EVO Visian ICL is indicated for phakic patients 21-45 years of age to correct/reduce myopia with up to 4.00 D of astigmatism with a spherical equivalent ranging from -3.00 to -20.0 D and with an anterior chamber depth (ACD) 3.0 mm or greater.

The EVO Visian ICL is contraindicated in patients with a true ACD of <3.00 mm; with anterior chamber angle less than Grade III; who have moderate to severe glaucoma; who are pregnant or nursing; who are less than 21 years of age; or who do not meet the minimum endothelial cell density (ECD) listed in the Directions For Use (DFU).

A summary of the relevant warnings, precautions and side effects: Endothelial cell loss, corneal edema, cataract, narrowing of the anterior chamber angle, pupillary block, increased intraocular pressure, glaucoma, secondary surgery to reposition, replace or remove the ICL, loss of BSCVA, increase in refractive astigmatism, glare and/or halos, pigment dispersion, iris transillumination defects, endophthalmitis, hypopyon, corneal endothelial damage, ICL dislocation, cystoid macular edema, iritis, retinal detachment, vitritis, and iris prolapse.

Please review the DFU for complete safety and other information before performing the clinical procedure.