This article is more than 5 years old. Information may no longer be current.

Presbia submits investigational device exemption for Flexivue Microlens

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Presbia has submitted an investigational device exemption to the U.S. Food and Drug Administration for the Flexivue Microlens as a solution for presbyopia.

The Flexivue Microlens is 3 mm in diameter and is implanted in the corneal stroma of the patient’s nondominant eye using femtosecond laser technology.

“The Presbia Flexivue Microlens has been implanted in more than 250 patients around the world since receiving its CE mark in 2009, which allowed its commercial use across 40 countries in Europe and Latin America,” Robert K. Maloney, MD, said in a press release. “I am excited to guide Presbia through the U.S. process of approvals for commercialization through the FDA.”

Maloney will serve as medical monitor for the investigational device exemption study of the Flexivue Microlens, which is a required part of the medical device approval process.

Presbia will initiate the study after the FDA approves the investigational device exemption.