Following more than 200,000 implantations across 75 countries since its international launch in 2024, Rayner has announced the spiral intraocular lens (IOL) platform has been approved by the United States Food and Drug Administration (FDA).
Galaxy’s FDA approval follows a successful Investigational Device Exemption study involving more than 250 patients across 10 US sites.
Rayner said the results showed a strong safety profile, with patient-reported outcomes demonstrating low levels of bothersome dysphotopsia, which the company described as a key differentiator compared with established presbyopia-correcting IOLs.
“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,” Rayner Chief Executive Officer Tim Clover said.
Galaxy is redefining expectations for full-range vision after cataract surgery…
“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.”
The IOL was unveiled at the 2024 European Society of Cataract and Refractive Surgeons congress in Barcelona and has been available to surgeons in Australia and New Zealand since January 2025.
