Irvine, CA—Visiogen Inc.'s dual-optic accommodating IOL (Synchrony) has received CE Mark designation.
"Having a CE Mark allows us to expand into post-marketing research studies within Europe to further build the scientific foundation for Synchrony," said Visiogen's President and CEO Reza Zadno, PhD. "As a result of this milestone, our product has moved beyond the early investigational stages and has been validated as a commercially viable product by an international regulatory body."
The lens is the first dual-optic accommodating lens for both cataract and refractive surgery, the company said in a prepared statement. The lens is designed to provide accommodation in patients undergoing cataract surgery who may or may not have a presbyopic condition. The dual-optic design of the lens can provide vision at all distances, without the optical limitations from multifocality, according to the company.