CORD, LLC, announced it has submitted a Premarket Approval (PMA) application to the FDA for the Model SC9 IOL for the treatment of cataracts.
The SC9 was developed by Stuart Cumming, MD, FACS, FRCOphth, who has been involved in the development of technology to improve and enhance vision for more than four decades. He holds more than 100 patents related to intraocular lenses.
Cumming designed the Crystalens, approved by the FDA in 2003.
The SC9 lens was designed to treat cataract patients with a single focus spherical optic and a rigid structure to consistently locate the optic in a position intended to provide intermediate vision that is superior to that of a standard monofocal IOL.
CORD is seeking market approval of the SC9 intraocular lens based on the results of more than 300 patients who were followed for a minimum of one year under an approved Investigational Device Exemption (IDE).