It is important to consider that EVO Visian® Implantable Collamer Lenses (ICL) are approved by the local health authority, which means they have been determined to be safe and effective. As with any procedure, there are risks to consider.
If you have any questions or concerns it is always best to speak with a certified EVO Visian® Implantable Collamer Lens (ICL) doctor.
The EVO Visian ICL family of lenses include EVO Visian ICL, EVO Visian Toric ICL, EVO+ Visian ICL, and EVO+ Visian Toric ICL and are designed for the correction/reduction of low to high myopia (-0.5 to -20.0 diopters (D)) and the correction/reduction of myopia in patients with up to -20 D of myopia with less than or equal to 6.0 D of astigmatism.
The EVO Visian ICL family is indicated for use in phakic eye treatment and for:
The correction/reduction of myopia in adults 21 – 60 years of age with power ranging from -0.5 D to -20.0 D at the spectacle plane. With an anterior chamber depth (ACD) equal to or greater than 3.0 mm, as measured from the corneal endothelium to the anterior lens capsule.
This extended age range covering over 45 to 60 years of age only applies to the myopic EVO Visian ICL family, and only in countries covered by the jurisdiction of the EU Notified Bodies where the CE Mark is recognised (i.e., the EU, EEA, and EFTA).
The EVO Visian ICL family of products currently in inventory do not have the updated Directions For Use (DFU) with this new wording yet, but it will be incorporated over time.
EVO Visian ICL surgery does not eliminate the need for reading glasses, even if you have never worn them before.
The EVO Visian 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 myopia such as contact lenses and eye glasses.
The EVO Visian Toric ICL is intended to correct or reduce astigmatism (up to 6.0 D) you may have (the EVO Visian ICL is not intended to treat your astigmatism).
Implantation of an EVO Visian 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, hyphema (blood in the eye), hypopyon (pus in the eye), eye infection, Visian ICL dislocation, macular edema, non-reactive pupil, pupillary block glaucoma, severe inflammation of the eye, iritis, uveitis, vitreous loss and corneal transplant.
Before considering EVO Visian ICL surgery you should have a complete eye examination and talk with your eye care professional about EVO Visian ICL surgery, especially the potential benefits, risks and complications.
You should discuss the time needed for healing after surgery.