Australia Approval for New IOL Technology

British IOL manufacturer, Rayner Intraocular Lenses Ltd., proudly announced today that it recently attained the coveted Therapeutic Goods Administration (TGA) clearance for sale of its intraocular lenses (IOLs) in Australia.

Rayner’s lenses are the first European IOLs to get TGA approval in over a decade. The TGA’s strict requirements over the years tended to restrict entry of new IOLs to Australia. This limited choice is about to change with Rayner’s entry into the market with the C-flex® injectable acrylic IOL system.

Dr Michael Coote, Ophthalmic Surgeon in Melbourne, Victoria commented that, “both surgeons and patients can be happy to welcome a lens which will allow us to enhance cataract surgery further in Australia”.

The new technology is already approved and widely used in Europe, Middle East, Asia, South America and South Africa. Mr. Richard Grills, the Managing Director of Designs For Vision, Rayner’s exclusive distributor in Australia and New Zealand, endorsed Dr Coote’s comments and went further: “We received encouragement from a number of surgeons to source and supply an intraocular lens which would allow the market a greater choice. However, it had to be the right product and company. Rayner, the manufacturer of the original IOL designed by the late Sir Harold Ridley, had the pedigree and long-term reputation. Now, with C-flex® we have a lens which is unique and offers patients significant clinical and long-term advantages”.

Mark Mullaney, the Regulatory Affairs Manager of Rayner, explained, “The C-flex® injectable acrylic IOL has our well-established AVHTechnology® plus the new and patented Enhanced Square Edge for reducing the risk of secondary cataract. The bio-compatible Rayacryl® material has an unmatched track record on sustained clarity and an absence of glare and unwanted imagery. The Anti-Vaulting Haptics provide excellent centration, no rotation and no vaulting and this largely contributes to accurate visual outcomes. But the system is more than just the lens. It is a “first”: the lens is uniquely packaged with a single-piece, single-use, disposable injector plus a sterile, transparent protective eye shield.”

The convenient combination of eye-shield, injector and lens all in the one pack has proved a strong selling point for Rayner elsewhere in the world and the company is counting on the same success in Australia.

Mr. Donald J Munro, Rayner’s Managing Director, said, “We are sure the ophthalmic surgeons and operating-room staff will welcome our technology. The patients certainly will appreciate the benefits. We’ve found an excellent partner in Designs For Vision and we look forward to working in the country. We also see TGA recognition as a milestone on the road to achieving a global marketing position for the company. It gives us encouragement because it shows the product has increasing, wide acceptance in the world’s premier ophthalmic markets.”

Contact: Mr. Richard Grills, Designs for Vision
Telephone: +61 2 9550 6966
Toll Free (Australia): 1 800 225 307
Email: richard@dfv.com.au
Website: www.dfv.com.au