This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: EVO/EVO+ VISIAN Implantable Collamer Lens (EVO ICL) and EVO/EVO+ VISIAN TORIC Implantable Collamer Lens (EVO TICL)
PMA Applicant: STAAR Surgical Company
Address: 1911 Walker Ave., Monrovia, CA 91016
Approval Date: March 25, 2022
Approval Letter: Approval order
What is it?
The EVO/EVO+ Visian Implantable Collamer and EVO/EVO+ Visian TORIC Implantable Collamer Lenses are artificial lenses permanently implanted inside the eye. The lens is intended to correct nearsightedness (myopia) and to correct blurred vision due to an irregularly shaped cornea (astigmatism).
How does it work?
The EVO/EVO+ Visian Implantable Collamer Lenses is intended to bend (refract) light rays to allow them to focus on the back surface of the eye, called the retina. The lens is placed in the area behind the iris and in front of the natural crystalline lens in an area called the posterior chamber. The device does not replace the natural crystalline lens.
When is it used?
The EVO/EVO+ Visian Implantable Collamer Lens is indicated for use in patients 21 to 45 years of age who are nearsighted. The EVO/EVO+ Visian TORIC Implantable Collamer Lens is used in patients 21 to 45 years of age who already have astigmatism and are also nearsighted.
What will it accomplish?
In a clinical study, EVO/EVO+ lenses have been shown to provide improved distance vision after implantation. The study followed 327 patients with either the EVO/EVO+ Visian Implantable Collamer Lens or the EVO/EVO+ Visian TORIC Implantable Collamer Lens. In that study, 75.9% (432/569) of patients reported 20/20 vision or better in the implanted eye, and 98.9% (563/569) of patients had 20/32 vision in the implanted eye after six months.
When should it not be used?
The EVO/EVO+ Visian Implantable Collamer and EVO/EVO+ Visian TORIC Implantable Collamer Lenses should not be used in patients who:
- Are pregnant or nursing
- Are less than 21 years old
- Have moderate to severe glaucoma
- Have eyes that aren’t the right shape for the lens due to a shallow space behind the cornea and in front of the iris of the eye (anterior chamber).
- Have an anterior chamber angle, which is the place where the iris and the cornea touch, that is too small (less than Grade III using gonioscopy).
- Do not have a minimal acceptable density of the thin, single layer of cells (endothelial cells) on the innermost surface of the cornea.
Additional information (including warnings, precautions, and adverse events):
- Summary of Safety and Effectiveness Data (SSED)
- Labeling Part 2 (Patient Information Booklet)
- PMA database entry