Rayner Receives FDA Approval for RayOne Spheric Monofocal IOL
Rayner has received FDA approval for the RayOne Spheric fully-preloaded monofocal IOL. The approval marks Rayner’s third FDA approval in under 3 years within its RayOne preloaded IOL portfolio. RayOne Spheric joins RayOne Aspheric (FDA approved December 2018) and RayOne EMV, a new non-diffractive IOL solution which achieved FDA approval on March 26, 2021.
RayOne Spheric is positioned as a cost-effective monofocal IOL solution and benefits from the same fully preloaded injector as its siblings, according to a company news release. The RayOne injector requires only two steps to prepare (load OVD and close the wings) and is compatible with sub 2.2 mm incisions.
All three FDA-approved RayOne IOLs are based upon the same hydrophilic acrylic platform, which offers superb stability (0.08 mm mean decentration at 3-6 months1), low PCO (1.7% at 24 months2), and high-quality vision with a high Abbe value (563) and low refractive index (1.463), according to Rayner.
RayOne Spheric expands the RayOne portfolio in the United States as an economical option relative to RayOne Aspheric and RayOne EMV, and is a cost-effective solution for patients who want a modern, high-quality monofocal IOL.
“Rayner strives to offer superior patient outcomes for all patients, and as a cost-effective solution, RayOne Spheric ensures that all US surgeons and patients can access the highest quality IOLs,” Tim Clover, Rayner CEO, said in a company news release. “This third FDA approval in less than 3 years supports our continued efforts to grow our available portfolio in the United States, which is a key strategic focus for Rayner.”
Patient outcomes for all RayOne IOLs can be tracked using RayPRO, a free contactless telehealth solution that collects three years’ worth of patient reported outcomes after cataract or refractive surgery.