{"id":20055,"date":"2026-09-24T10:20:02","date_gmt":"2026-09-24T09:20:02","guid":{"rendered":"https:\/\/rayner.com\/us\/?p=20055"},"modified":"2026-09-24T10:20:46","modified_gmt":"2026-09-24T09:20:46","slug":"rayner-announces-fda-approval-of-galaxy-the-worlds-first-spiral-iol","status":"publish","type":"post","link":"https:\/\/rayner.com\/us\/rayner-announces-fda-approval-of-galaxy-the-worlds-first-spiral-iol\/","title":{"rendered":"Rayner Announces FDA Approval of Galaxy, the World’s First Spiral IOL"},"content":{"rendered":"

Following more than 200,000 implantations across 75 countries since its international launch in 2024, Rayner today announced the FDA approval and US commercial availability of RayOne Galaxy and RayOne Galaxy Toric, the world\u2019s first spiral IOL platform.<\/p>\n

Developed with AI, Galaxy’s non-diffractive spiral optic delivers a smooth and continuous full range of vision with minimized dysphotopsia and 0% loss of transmitted light.1 Unlike traditional diffractive lenses that use steps or rings to split light, Galaxy\u2019s unique spiral design is engineered to significantly reduce the halo and glare often associated with advanced IOL technologies.<\/p>\n

Galaxy\u2019s FDA approval follows a successful Investigational Device Exemption (IDE) study involving more than 250 patients across 10 US sites. Results showed a strong safety profile, with patient-reported outcomes demonstrating low levels of bothersome dysphotopsia \u2013 a key differentiator compared with established presbyopia-correcting IOLs.<\/p>\n

Eric Donnenfeld MD, Cornea, Laser Cataract & Refractive Surgeon at OCLI Vision, an IDE study investigator, commented: \u201cFor years, advanced optics have required patients to accept a degree of compromise, whether that’s unwanted halos or reduced contrast sensitivity. Participating in this study, I saw firsthand that those trade-offs are no longer inevitable. Galaxy combines a continuous range of vision with the visual quality patients expect today, and feedback has been exceptional. I believe Galaxy will fundamentally change expectations for full-range vision correction among both surgeons and patients in the US.\u201d<\/p>\n

The launch marks another significant milestone for Rayner in the United States, following recent FDA clearances for RayOne EMV Toric and the Sophi Phacoemulsification System, further strengthening the company’s premium portfolio.<\/p>\n

\u201cBuilding 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. 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.\u201d said Tim Clover, CEO, Rayner.<\/p>\n

US surgeons can explore the Galaxy spiral IOL platform at the upcoming AAO Annual Meeting in New Orleans, or by contacting their local Rayner representative. For more information and to be one of the first US users, visit www.rayner.com\/Galaxy<\/a>.<\/p>\n

References:<\/strong><\/p>\n

    \n
  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.<\/li>\n<\/ol>\n

    About Rayner:<\/strong><\/p>\n

    Since the implantation of the first Rayner intraocular lens by Sir Harold Ridley in 1949, Rayner has had the goal to improve vision and restore sight worldwide. Today, Rayner\u2019s mission remains to deliver innovative and clinically superior ophthalmic products that respond to the expectations of our global customers to improve the sight and quality of life of their patients.<\/p>\n

    Headquartered in Worthing, United Kingdom, Rayner markets its medical devices, pharmaceuticals, and digital solutions globally through a network of distributors and includes direct sales teams in the United Kingdom, Eire, USA, Canada, Brazil, India, Poland, Australia, Germany, Austria, Switzerland, France, Italy, Spain, and Portugal.<\/p>\n

    Not all Rayner products are approved for sale in every country. Please contact your local Rayner distributor for details of which products are available in your area.<\/p>\n

    \u00a92026 Rayner Group, all rights reserved. \u2018Rayner\u2019 \u2018RayOne\u2019 and \u2018Galaxy\u2019 are proprietary marks of the Rayner Group. All other trademarks are property of their respective owners. Rayner, The Ridley Innovation Centre, 10 Dominion Way, Worthing, West Sussex, BN14 8AQ. Registered in England: 615539 | EC 2026-71 EN<\/p>\n","protected":false},"excerpt":{"rendered":"

    Following more than 200,000 implantations across 75 countries since its international launch in 2024, Rayner today announced the FDA approval and US commercial availability of RayOne Galaxy and RayOne Galaxy Toric, the world\u2019s first spiral IOL platform. Developed with AI, Galaxy’s non-diffractive spiral optic delivers a smooth and continuous full range of vision with minimized<\/p>\n","protected":false},"author":368,"featured_media":20047,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[946],"tags":[],"class_list":["post-20055","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company"],"acf":[],"yoast_head":"\nRayner Announces FDA Approval of Galaxy, the World's First Spiral IOL - Rayner : USA<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/rayner.com\/us\/rayner-announces-fda-approval-of-galaxy-the-worlds-first-spiral-iol\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Rayner Announces FDA Approval of Galaxy, the World's First Spiral IOL - Rayner : USA\" \/>\n<meta property=\"og:description\" content=\"Following more than 200,000 implantations across 75 countries since its international launch in 2024, Rayner today announced the FDA approval and US commercial availability of RayOne Galaxy and RayOne Galaxy Toric, the world\u2019s first spiral IOL platform. 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