Staar Surgical (NSDQ:STAA) said today it won approval from Health Canada’s Medical Devices Bureau for its Evo Visian Toric ICL intraocular lenses.
The Evo Visian Toric ICL is designed to be implanted inside the eye between the iris and the natural lens indefinitely to correct vision, Monrovia, Calif.-based Staar Surgical 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 looks forward to training Canadian surgeons on the EVO Toric ICL at the upcoming American Academy of Ophthalmology 2016 Annual Meeting in Chicago in October, then bringing this visual freedom choice to the Canadian refractive surgery market,” prez & CEO Caren Mason said in an SEC filing.
Last week, Staar Surgical said it inked a distribution agreement with India-based EyeQ Vision Private to distribute Staar Evo Visian ICL intraocular lenses as a treatment for refractive vision treatment.
The deal includes supplying the lenses to 44 hospitals in north and west India, with plans to increase the number to 70 hospitals, including south and west India, within the next 2 years.
Last month, Staar Surgical offered updates on the FDA warning it received in February as it released its quarterly earnings. The company received the warning about its plant in Monrovia, Calif., after FDA inspections found 10 problems with the way Staar documents product changes and other issues.