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ClarVista obtains CE mark for Harmoni modular IOL system

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ClarVista Medical has received CE mark approval and quality standard ISO 13485 certification for its Harmoni modular IOL system to correct vision in aphakic patients after cataract lens removal, according to a press release.

“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.

The system enables a safe exchange of the optic component to reduce residual refractive error at the time of surgery or 3 months postoperatively.

In addition, early data showed a significant reduction in the development of secondary cataracts, 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.”