Rayner announced that the FDA has cleared the RayOne Aspheric fully preloaded IOL injection system for use in the United States.
The FDA granted regulatory clearance of the RayOne Aspheric Monofocal (RAO600C), a fully preloaded aberration-neutral IOL covering a power range of +8.0 D to +34.0 D.
When creating the RayOne system, Rayner developed their new MICS lens and fully preloaded IOL injection system with patented Lock & Roll technology as part of the same design process. This combination has resulted in the smallest fully preloaded injector nozzle available – a 1.65 mm nozzle tip diameter for sub 2.2 mm delivery.
Lock & Roll technology rolls the lens to under half its size in one simple action, allowing the lens to pass smoothly though the fully enclosed cartridge, without the need for lens handling. This minimizes insertion force and enables a consistently smoother delivery.
The new RayOne Aspheric MICS lens is an enhanced version of the C-flex platform with an improved single 6.0 mm optic design. The material and design benefits of the original lens has been retained, without compromising on proven stability or optical performance, according to Rayner.
The RayOne Aspheric preloaded injector delivers the IOL consistently with expert control, through a micro incision with minimal wound stretch.
The FDA approval of RayOne Aspheric is the third in a pipeline of commercial and regulatory plans which Rayner will be executing over the next 5 years, according to Rayner, which says it is commited to transforming itself into one of the major players in the US market.
“We are delighted that the FDA has approved RayOne Aspheric for commercial distribution in the United States,” James Crutchlow, Director of North America, said in a company news release. “The approval completes what has been a transformative 12 months for Rayner in the United States, which began with the opening of the dedicated New York office and has since included FDA approvals for the 600C IOL and our new state-of-the-art manufacturing facility. To now bring our flagship RayOne Aspheric product to the world’s largest healthcare market and provide US healthcare professionals with the smallest fully preloaded incision is an ideal way to close 2018. We look forward to introducing this latest innovation in preloaded technology and building on the 600,000 OUS implantations of RayOne Aspheric.”