December 09, 2022
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CORD submits premarket approval application for SC9 IOL
CORD has submitted a premarket approval application to the FDA for the Model SC9 IOL to treat patients with cataracts, according to a press release.
The lens was designed by J. Stuart Cumming, MD, FACS, FRCOphth, to provide intermediate vision superior to that of a standard monofocal IOL. It has a single-focus spherical optic and a rigid structure to locate the optic to provide intermediate vision.
Source: Adobe Stock.
The application is backed by the results of more than 300 patients who were followed for at least 1 year under an approved investigational device exemption, according to the release.
Cumming is also the designer of the Crystalens IOL, now owned by Bausch +Lomb, which was approved by the FDA in 2003.