Rayner Secures FDA Approval for RayOne EMV Toric IOL
Posted on 13/10/2025
FDA approval expands US access to award-winning lens technology
Rayner today announced that the US Food and Drug Administration (FDA) has approved its RayOne EMV Toric intraocular lens (IOL) following the successful completion of a pivotal Investigational Device Exemption (IDE) study. The lens is now available to US surgeons seeking to deliver high quality visual outcomes for patients with astigmatism.
Engineered for exceptional rotational stability and refractive precision, RayOne EMV Toric expands Rayner’s trusted EMV platform, developed in collaboration with world-renowned ophthalmic surgeon Professor Graham Barrett. Since its first launch in 2020, the EMV family has become a global platform of choice, with lenses shipped to more than 75 countries, including the US.
The multicenter, randomized, active-controlled FDA trial enrolled 238 patients who received either the RayOne EMV Toric or the control monofocal IOL (RayOne Aspheric).
- At Day 1-2 post-op, RayOne EMV Toric demonstrated an absolute mean rotation of just 0.9°.1
- At Month 6, RayOne EMV Toric showed absolute mean lens alignment of only 3.5°, with at least 99% of eyes rotating ≤5°, exceeding FDA requirements.1
These results confirm exceptional rotational stability, supporting effective visual performance and reliable astigmatism correction.
The RayOne EMV platform is built on a patented non-diffractive optic design that utilizes controlled positive spherical aberration; it does not use light splitting technology like many IOLs which increase depth of focus. This optical design delivers high-quality vision1, with monofocal levels of contrast sensitivity2, and low dysphotopsia3. The platform’s innovation and high levels of patient satisfaction were recently recognized with the 2025 King’s Award for Enterprise in the Innovation category.
Dr. William Wiley of the Cleveland Eye Clinic, an IDE study investigator, commented:
“In my experience, the RayOne EMV Toric performed exceptionally well – delivering excellent visual outcomes with the added benefit of outstanding rotational stability. I’m confident this lens will become an important option for patients who want both refractive precision and stability. It’s an honor to have been part of the FDA study and to help bring this innovation to US surgeons.”
Rayner CEO Tim Clover added: “The long-awaited FDA approval of RayOne EMV Toric is a major milestone in our mission to expand global access to advanced IOL technologies. My heartfelt thanks go to the surgeons and patients who participated in the trial – the clinical results speak for themselves.”
US ophthalmologists will be able to discover RayOne EMV Toric at the American Academy of Ophthalmology (AAO) congress in Orlando, 18-20 October 2025, or online at www.rayner.com/emv
References:
- Rayner RayOne EMV Toric FDA IDE study (G230072).
- Ferreira TB. Presented at ESCRS 2022 [Paper].
- Findl O. et al. Am J Ophthalmol. 2024; 271:86-95.
About Rayner:
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’s 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.
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.
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.
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