In 1981 the Rayner Anterior Chamber lenses (Choyce Mark VIII and MkIX) were the first IOLs to be approved as safe and effective by the the US Food and Drug Administration (FDA).
Twenty two years later, in 2003, Rayner announced the start of an FDA approved multi-centre clinical investigation of the C-flex® injectable IOL, at seven sites in the USA and Europe. The multi-site study opened the way for Rayner to supply US surgeons with a new technology lens that is already approved and widely used in Europe, Middle East, Asia, South America and South Africa.
The study “meets and exceeds the FDA’s stringent standards of product safety and efficacy”, said Mark Mullaney, then Regulatory Affairs Manager for Rayner Intraocular Lenses Ltd.
The first US patient was implanted “beautifully” with a C-flex® lens on October 24, 2003 by Dr James A. Davison at the Wolfe Clinic, Marshalltown, Iowa, who said that the lens injection system worked particularly well, “the thumb pressure required was very even throughout the injection process, but surprisingly easy to accomplish. Resistance was smooth, even and continuous throughout the entire injection process and the lens centered exceptionally well.” He was also pleased to add that “the positioning and orientation of the lens in the single-piece, single-use injector using a little viscoelastic was easy to achieve and very intuitive”.
Thus Rayner returned to the USA after a gap of over 20 years. In 1981 a Rayner lens was the first IOL ever to be approved by the FDA as “safe and effective”. The C-flex® lens re-established Rayner’s position as the IOL producer of the highest quality and innovation in the market today.
The C-flex® system lens is an injectable hydrophilic acrylic lens with AVH Technology® and the patented new Enhanced Square Edge for reducing PCO. The lens is packaged with a single-piece, single-use injector and a sterile, transparent protective eye shield. The combination of the injector and lens in the same pack makes it extremely convenient for the surgeon and staff to use. Dr Davison commented, “the injector and lens were easily accessed within the sterile packaging and the directions were very clear”.
After carrying out his first procedure with the new system Dr I. Howard Fine reported, “this is great technology. The injector tip went in easily through a 2.8 mm incision ... the lens centered by itself and it looked splendid”. Dr Mark Packer in Eugene OR, remarked that, “delivery is the best controlled and simplest that I’ve seen. The lens centers superbly and it looks stunning in the eye. The lens goes into the eye so quietly” and Dr Davison observed that, “there were no marks or scratches created on the optic, and no deformities were created in the haptic architecture.”
The comprehensive study of the C-flex® injectable lens system took place in six sites, including four in the United States (Salt Lake City UT, Eugene OR, Encino CA and Marshalltown IA). The other sites were at Vienna in Austria and Heidelberg and Marburg in Germany.
