Rayner’s RayOne Aspheric preloaded IOL launches in China
Rayner announced that its RayOne Aspheric fully preloaded IOL injection system has been approved by the Chinese regulator, National Medical Products Administration (NMPA), and is now available for commercial use in China.
The NMPA granted regulatory approval and sale of the 6.0 mm RayOne Aspheric (RAO600C) monofocal IOL for the full power range from -10.0 D to +34.0 D.
“Renowned for its ease of use, the availability of RayOne Aspheric is an exciting development for ophthalmologists in China. I have been a long-time user of the C-flex Aspheric IOL and have high confidence in Rayner’s latest innovation living up to its reputation for performance and outcomes. I am very much looking forward to offering RayOne Aspheric to my patients,” Professor Zhu Siquan, Director of Ophthalmology Department, Beijing Tongren Hospital, said in a company news release.
Lens and Injector Designed as One
When creating the RayOne system, Rayner developed its Micro Incision Cataract Surgery (MICS) lens and fully preloaded IOL injection system as part of the same design process. This combination has resulted in the smallest fully preloaded injector nozzle available, enabling a sub-2.2 mm incision.
The RayOne injector’s Lock & Roll technology rolls the lens to under half its size in one simple action, allowing the lens to pass smoothly through the fully enclosed cartridge, without the need for lens handling. This minimizes insertion force and enables a consistently smoother delivery.
What does this mean for cataract and refractive surgeons?
RayOne offers an injector that delivers the IOL consistently, with expert control, through a micro incision with minimal wound stretch, according to Rayner. The simple 2-step preparation also means a minimal learning curve for surgeons’ operating room staff, and ultimately more efficient cataract procedures.
Strong relationships and solid foundations for growth in China
‘‘Discussions with surgeons in China confirmed that there was a need for a more premium product to be offered in addition to our longstanding C-flex/Superflex monofocal IOLs, so I am very happy with our RayOne Aspheric NMPA approval and am grateful to everyone involved in the stringent application process,” Cary Dawes, Rayner Vice President International, said in the news release. “Zhu Geng and the dedicated team at Beijing Cambridge have been Rayner’s exclusive distributor in China for over 15 years, building close relationships with surgeons and the Rayner brand, so I’m confident that we will have a strong local launch. These solid foundations also place us in a strong position as we make more of the RayOne preloaded IOL family available in China over the coming years.’’
In partnership with their regulatory agency Tigermed, Rayner will look to make further NMPA applications for its RayOne EMV and initiate a clinical study with RayOne Trifocal in the near future.
