OCT 02, 2015
A modular IOL system designed to improve vision after cataract surgery has received CE mark approval and quality standard ISO 13485 certification.
ClarVista says the Harmoni modular IOL consists of a base and optic component, which allows for the safe exchange of the optic component to reduce residual refractive error during surgery or 3 months postoperatively. The company says it’s ideally suited for optimizing visual outcomes in multifocal and toric IOL patients.
Implanted through a 2.2 mm incision and made of hydrophobic acrylic material, the 2 components are assembled within the eye with the optic fitting entirely within the rhexis.
“While these are noteworthy regulatory milestones achieved by ClarVista, this news is also of great significance for physicians and patients around the world who seek optimum vision after cataract extraction,” co-inventor Malik Kahook, MD, said in the release.
Additionally, early data shows a significant reduction in the development of posterior capsule opacification and more predictable effective lens position, the release said.
“We are also working hard on adding further value to our platform technology,” Kahook said. “The Harmoni modular IOL system really has the opportunity to disrupt the $3 billion global market for IOLs.”