Safety Information
It’s important to consider that the EVO Visian ICL (EVO) is FDA approved which means it has been determined to be a safe and effective procedure. 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 Visian ICL doctor. Please view the Patient Information Booklet for full information.
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Important Safety Information
The EVO Visian ICL Lens is intended for the correction of moderate to high nearsightedness. EVO Visian ICL and EVO Visian TICL surgery is intended to safely and effectively correct nearsightedness between -3.0 D to -15.0 D, the reduction in nearsightedness up to -20.0 D and treatment of astigmatism from 1.0 D to 4.0 D. If you have nearsightedness within these ranges, EVO Visian ICL surgery may improve your distance vision without eyeglasses or contact lenses. Because the EVO Visian ICL corrects for distance vision, it does not eliminate the need for reading glasses, you may require them at some point, even if you have never worn them before.
Implantation of the EVO Visian ICL is a surgical procedure, and as such, carries potentially serious risks. Please discuss the risks with your eye care professional. Complications, although rare, may include need for additional surgical procedures, inflammation, loss of cells from the back surface of the cornea, increase in eye pressure, and cataracts.
You should NOT have EVO Visian ICL surgery if:
- Your doctor determines that the shape of your eye is not an appropriate fit for the EVO Visian ICL
- You are pregnant or nursing
- You have moderate to severe damage to the optic nerve caused by increased pressure (glaucoma)
- You do not meet the minimum endothelial cell density for your age at the time of implantation as determined by your eye doctor
- Your vision is not stable as determined by your eye doctor
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. For additional information with potential benefits, risks and complications please visit DiscoverICL.com.
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References
¹Patient Survey, STAAR Surgical ICL Data Registry, 2018
²Sanders 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.
³Naves, 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.
⁴Shoja, MR. Besharati, MR. Dry eye after LASIK for myopia: Incidence and risk factors. European Journal of Ophthalmology. 2007; 17(1): pp. 1-6.
5aLee, 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.
5bParkhurst, 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.
⁶Martínez-Plaza E, López-Miguel A, López-de la Rosa A, et al. Effect of the EVO+ Visian Phakic Implantable Collamer Lens on Visual Performance and Quality of Vision and Life, Am J Ophthalmol 2021;226:117-125.
⁷Packer M. Evaluation of the EVO/EVO+ Sphere and Toric Visian ICL: Six month results from the United States Food and Drug Administration clinical trial. Clinical Ophthalmology. 2022;16:1541-53.
⁸Parkhurst GD. A prospective comparison of phakic collamer lenses and wavefront-optimized laser-assisted in situ keratomileusis for correction of myopia. Clin Ophthalmol. 2016;10:1209-1215.
⁹Ganesh S, Brar S, Pawar A. Matched population comparison of visual outcomes and patient satisfaction between 3 modalities for the correction of low to moderate myopic astigmatism. Clin Ophthalmol. 2017;11:1253-1263.