Rayner has announced that the US Food and Drug Administration (FDA) has approved its RayOne EMV Toric intraocular lens (IOL).
In a media release it said the approval followed 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.
Rayner said the lens was engineered for exceptional rotational stability and refractive precision, expanding its EMV platform.
It was developed in collaboration with world-renowned Australian ophthalmic surgeon Professor Graham Barrett.
Image: Graham Barrett.
Since its launch in 2020, lenses from the EMV family had been shipped to more than 75 countries, including the US.
The multi-centre, randomised, 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 confirmed 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 uses 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 recognised with the 2025 King’s Award for Enterprise in the Innovation category.
Dr William Wiley of the Cleveland Eye Clinic, an IDE study investigator, said: “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 honour to have been part of the FDA study and to help bring this innovation to US surgeons.”
Rayner CEO Mr 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.”
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.
