Staar Surgical Company has received approval from the Medical Devices Bureau of Health Canada for its Evo Visian Toric implantable collamer lens (ICL).
The approval allows the company to market Evo Visian Toric ICL in the country.
The Evo and EVO Toric IC, which is the next-generation lens implanted in the eye, works with the patient's natural eye to correct vision.
Evo lenses will be placed inside the eye between the iris and the natural lens, while the traditional contact lenses are placed on the surface of the eye.
With its central hole, the EVO provides enhanced refractive outcomes by eliminating the extra surgical step of the peripheral iridotomy.
According to the company, the clinical data demonstrated that the EVO ICL provides predictable correction of high degrees of refractive errors with majority of patients achieving and maintaining 20/20 or better visual acuity through five years of follow up.
Staar Surgical Company president and CEO Caren Mason said: "We are very pleased with Health Canada's approval that allows us to offer the EVO Toric ICL for myopia and astigmatism, with a broad spherical power range of -3.0 to -18.0 diopters and cylinder power range of 1.0 to 6.0 diopters, to our surgeons and their patients in Canada.
“This represents an important new option for eligible patients between 21 and 45 years old living with nearsightedness and astigmatism treated in a single procedure.”
“This approval reinforces our deep commitment to patients seeking visual freedom, as we continue to expand our EVO ICL portfolio globally.”
Staar Surgical is engaged in the development, manufacturing and marketing of implantable lenses and companion delivery systems for the eye.