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Safety Information

It’s important to consider that EVO is approved by the local health authority, which means it has been determined to be safe and effective. As with any procedure, there are risks to consider.
If you have any questions or concerns it's always best to speak with a certified EVO doctor.

The EVO Visian ICL & EVO TICL is designed for the correction of moderate to high near-sightedness (-0.5 to -20.0 dioptres (D)) and the reduction of near-sightedness in patients with up to -20 dioptres (D) of near-sightedness with less than or equal to 6.0 dioptres (D) of astigmatism.

It is indicated for patients who are 21 to 60 years of age.
In order to be sure that your surgeon will use an EVO with the most adequate power for your eye, your near-sightedness should be stable for at least a year before undergoing eye surgery.
EVO surgery has been documented to safely and effectively correct near-sightedness between -0.5 dioptres (D) to -20.0 dioptres (D) and partially correct near-sightedness up to -20 dioptres in eyes with up to 6.0(D) of astigmatism.
If you have near-sightedness within these ranges, EVO surgery may improve your distance vision without eyeglasses or contact lenses.
EVO surgery does not eliminate the need for reading glasses, even if you have never worn them before.
The EVO 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 is not intended to correct any astigmatism you may have.
Implantation of the EVO is a surgical procedure, and as such, carries potentially serious risks.
The following represent potential complications/adverse events reported in conjunction with refractive surgery in general: 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 surgery you should have a complete eye examination and talk with your eye care professional about EVO surgery, especially the potential benefits, risks and complications.
You should discuss the time needed for healing after surgery.

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Important Safety Information

The EVO Visian ICL & EVO Visian TICL is 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 Visian 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+ Visian ICL 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 EVO Visian 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 EVO Visian 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. EVO Visian ICL surgery may improve your vision without eyeglasses or contact lenses. EVO Visian ICL surgery does not eliminate the need for reading glasses, even if you have never worn them before. 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 your vision such as contact lenses and eye glasses. 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, hyphaema (blood in the eye), hypopyon (pus in the eye), eye infection, EVO Visian ICL dislocation, macular oedema, 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.

References

References

1. Patient Survey, STAAR Surgical ICL Data Registry, 2018

2. Sanders D. Vukich JA. Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for Low Myopia. Cornea. 2006 Dec; 25(10):1139-46. Patient Survey, STAAR Surgical ICL Data Registry, 2018

3. Naves, J.S. Carracedo, G. Cacho-Babillo, I. Diadenosine Nucleotid Measurements as Dry-Eye Score in Patients After LASIK and ICL Surgery. Presented at American Society of Cataract and Refractive Surgery (ASCRS) 2012.

4. Shoja, MR. Besharati, MR. Dry eye after LASIK for myopia: Incidence and risk factors. European Journal of Ophthalmology. 2007; 17(1): pp. 1-6.

5a. Lee, Jae Bum et al. Comparison of tear secretion and tear film instability after photorefractive keratectomy and laser in situ keratomileusis. Journal of Cataract & Refractive Surgery , Volume 26 , Issue 9 , 1326 - 1331.

5b. Parkhurst, G. Psolka, M. Kezirian, G. Phakic intraocular lens implantantion in United States military warfighters: A retrospective analysis of early clinical outcomes of the Visian ICL. J Refract Surg. 2011;27(7):473-481.

*American Refractive Surgery Council