Key Takeaways

  • The FDA has approved RayOne Galaxy and RayOne Galaxy Toric for commercial availability in the US
  • The non-diffractive spiral optic is designed to provide a continuous range of vision while minimizing halos, glare, and other bothersome dysphotopsias
  • FDA approval followed an IDE study involving more than 250 patients at 10 US clinical sites

Rayner announced FDA approval and US commercial availability of its RayOne Galaxy and RayOne Galaxy Toric IOLs, bringing the company’s spiral optic platform to US cataract surgeons.

The US launch follows more than 200,000 implantations across 75 countries since the platform’s international introduction in 2024, according to the company.

Developed using artificial intelligence, the RayOne Galaxy platform features a non-diffractive spiral optic designed to provide a smooth, continuous range of vision while minimizing dysphotopsia. Rayner said the technology provides 0% loss of transmitted light.1 Unlike conventional diffractive IOLs, which use steps or rings to split light, the spiral design is intended to reduce halos and glare associated with some presbyopia-correcting IOL technologies.

FDA approval followed an Investigational Device Exemption (IDE) study that enrolled more than 250 patients at 10 sites in the United States. According to Rayner, study results demonstrated a strong safety profile, while patient-reported outcomes showed low levels of bothersome dysphotopsia.

Eric Donnenfeld, MD, a cornea, laser cataract, and refractive surgeon at OCLI Vision and an investigator in the IDE study, said the technology may address some of the visual-quality trade-offs historically associated with advanced IOLs.

“For years, advanced optics have required patients to accept a degree of compromise, whether that's unwanted halos or reduced contrast sensitivity,” Dr. Donnenfeld said. “Participating in this study, I saw firsthand that those trade-offs are no longer inevitable.”

The approval expands Rayner’s portfolio in the United States following recent FDA clearances for the RayOne EMV Toric IOL and Sophi Phacoemulsification System.

“Building on the momentum we've seen from surgeons and patients globally, we're excited to introduce the world's first spiral IOL platform to the US market,” said Tim Clover, CEO of Rayner. “Galaxy is redefining expectations for full-range vision after cataract surgery, and we look forward to partnering with US surgeons to make this technology available to their patients.”

Rayner said US ophthalmologists will be able to explore the RayOne Galaxy platform at the upcoming American Academy of Ophthalmology Annual Meeting in New Orleans and through local Rayner representatives.

Reference

1. Abela-Formanek C et al. Performance of the First Spiral Refractive Intraocular Lens for Continuous Full Range of Vision. J Refract Surg. 2025 Nov;41(11):e1213-e1222.