New IOL technology to US market

Rayner (headquartered in the UK) announced today that the clinical investigation of the C-flex® injectable intraocular lens (IOL) system has started. Donald J. Munro, CEO of LA-based RAYNER SURGICAL INC., said that the study was, “well and truly underway” at all US and European sites. Mr Munro explained that the multi-site study will open 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”, says Mark Mullaney, Regulatory Affairs Manager for Rayner Intraocular Lenses Ltd. in England who design and manufacture the lens and its injector at their facility in Hove, East Sussex.

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”.

Rayner is back in 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”. Mr Munro said that, “the C-flex® lens will re-establish Rayner’s position as the IOL producer of the highest quality and innovation in the market today. We are very excited to be back in the US market”.

The C-flex® system lens is an injectable hydrophilic acrylic lens withAVH 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”. Mike Ring, Rayner’s Director of Operations, commented, “the transparent eye shield allows the patient to appreciate immediately the advantages of the implant procedure”.

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 is currently taking place in six sites, including three in the United States (Salt Lake City UT, Eugene OR and Marshalltown IA). The other sites are Vienna in Austria and Heidelberg and Marburg in Germany.