The United States Food and Drug Administration (FDA) has approved Rayner’s RayOne EMV Toric intraocular lens (IOL) following the successful completion of a pivotal Investigational Device Exemption (IDE) study. The lens, which in Australia has been approved for three years and implanted in thousands of eyes, is now available to United States surgeons seeking to deliver high quality visual outcomes for patients with astigmatism.
Engineered for exceptional rotational stability and refractive precision, RayOne EMV Toric was developed in collaboration with world-renowned Australian ophthalmic surgeon Professor Graham Barrett.
The multicentre, randomised, active-controlled FDA trial enrolled 238 patients who received either the RayOne EMV Toric or the control monofocal IOL (RayOne Aspheric).
- At day one to two post-op, RayOne EMV Toric demonstrated an absolute mean rotation of just 0.9°.1
- At month six, 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 platform is built on a patented non-diffractive optic design that utilises 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 recognised with the 2025 King’s Award for Enterprise in the Innovation category.
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.