Rayner announced 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, the company said in a press release. RayOne EMV Toric expands the company's EMV platform that was developed in collaboration with ophthalmic surgeon Professor Graham Barrett.
According to Rayner, 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 the first and second days following the operation, 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°. According to the company, this exceeds FDA requirements.1
The company said these results confirm rotational stability, which supports visual performance and astigmatism correction.
According to Rayner, the RayOne EMV platform is built on a patented nondiffractive 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 vision,1 with monofocal levels of contrast sensitivity,2 and low dysphotopsia.3
References
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Rayner RayOne EMV Toric FDA IDE study (G230072).
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Ferreira TB. Presented at: the European Society of Cataract and Refractive Surgeons (ESCRS) Meeting; 2022.
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Findl O, Zeilinger J, Kronschläger M, et al. Comparing an advanced monofocal with a nondiffractive extended depth of focus intraocular lens using a mini-monovision approach. Am J Ophthalmol. 2025;271:86-95. doi:10.1016/j.ajo.2024.10.014