Rayner Secures FDA Approval for RayOne EMV Toric IOL
The FDA has approved Rayner's RayOne EMV Toric IOL following the completion of a pivotal investigational device exemption (IDE) study.
According to Rayner, the RayOne EMV Toric lens has been engineered to provide exceptional rotational stability and refractive precision. It expands Rayner’s EMV platform, which was developed in collaboration with ophthalmic surgeon Professor Graham Barrett.
In the multicenter, randomized, active-controlled FDA IDE trial, 238 patients were implanted with either the RayOne EMV Toric or the control monofocal IOL (RayOne Aspheric). Key findings include:
Day 1–2 post-op: Absolute mean rotation of just **0.9°**¹
Month 6: Mean lens alignment of 3.5°, with ≥99% of eyes rotating ≤5°, exceeding FDA benchmarks¹
The RayOne EMV platform features a patented non-diffractive optic design that uses controlled positive spherical aberration rather than light-splitting technology typically used to increase depth of focus. This approach enables:
High-quality visual acuity comparable to monofocal lenses¹
Monofocal-level contrast sensitivity²
Low incidence of dysphotopsia³
The EMV platform’s innovation and patient satisfaction were recently recognized with the 2025 King’s Award for Enterprise in Innovation.
“In my experience, the RayOne EMV Toric performed exceptionally well – delivering excellent visual outcomes with the added benefit of outstanding rotational stability," said William Wiley, MD, of the Cleveland Eye Clinic, a principal investigator in the FDA IDE study. "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.”
U.S. ophthalmologists will have the opportunity to explore the RayOne EMV Toric at the upcoming American Academy of Ophthalmology (AAO) Congress in Orlando, October 18–20, 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.