Rayner announced today that it is marking an important milestone this month- the 10-year anniversary of US Food and Drug Administration (FDA) approval of the C-flex 570C monofocal Intraocular Lens (IOL) for commercial use in the United States of America. During cataract surgery, the clouded natural lens of the eye is dissolved by a process called phacoemulsification. The lens is then replaced with a clear intraocular lens. C-flex — the first IOL from a non-American manufacturer in over two decades to gain FDA approval, is a key product of Rayner’s and is one of the company’s most implanted lenses globally.
Dr James A Davison at the Wolfe Eye Clinic, Marshalltown, Iowa, implanted the first US patient with a C-flex IOL on October 24, 2003 as part of the international, multi-site clinical study (a pre-requisite for FDA approval). Dr Davison said: “It was a great privilege to be part of the study for the Rayner foldable acrylic IOL and I join in celebrating its 10-year anniversary. This lens has a unique and extremely stable three-dimensional haptic structure and beautifully clear optic. It is easy to implant and centers very predictably. I really enjoy seeing it in my patients today.”
Rayner CEO, Tim Clover, said: “I would like to personally thank all surgeons who have contributed to our growth in the USA. We will continue to work hard in providing the US market with access to existing products as well as products in our pipeline, all with the ambition of delivering better patient outcomes.”