FDA approves Rayner’s RayOne EMV Toric intraocular lens

The US Food and Drug Administration (FDA) has approved Rayner’s RayOne EMV Toric intraocular lens (IOL). The approval follows the successful completion of a pivotal Investigational Device Exemption (IDE) study.¹

As defined by the FDA, an IDE allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Additionally, an approved IDE permits a device to be “shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (FD&C Act) that would apply to devices in commercial distribution.”²

The multicenter, randomized, active-controlled FDA trial enrolled 238 patients who received either the RayOne EMV Toric or RayOne Aspheric, the control monofocal IOL.

According to the company, results showed that at day 1-2 post-op, RayOne EMV Toric demonstrated an absolute mean rotation of just 0.9°, and at month 6, RayOne EMV Toric showed absolute mean lens alignment of only 3.5°, with at least 99% of eyes rotating ≤5°.¹

William Wiley, MD, of the Cleveland Eye Clinic and an IDE study investigator, commented on the trial in a press release from the company, saying, “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.”¹

The company defines the RayOne EMV platform as being built on a “patented non-diffractive optic design that utilizes controlled positive spherical aberration and does not use light-splitting technology like many IOLs, which increase depth of focus.” Furthermore, this optical design delivers high-quality vision, with monofocal levels of contrast sensitivity and low dysphotopsia, according to the company.¹

Rayner intends for the RayOne EMV Toric to be displayed at the upcoming American Academy of Ophthalmology (AAO) congress in Orlando, 18-20 October 2025.

At the beginning of 2025, Rayner announced the launch of a redesign for its online premium IOL calculator, RayTrace. The 4.0 version reflects surgeon feedback with quicker and clearer calculations and allows access to the PEARL DGS formula, among other features.

References:

1. Rayner Secures FDA Approval for RayOne EMV Toric IOL. Published October 13, 2025. Accessed October 15, 2025. https://rayner.com/us/rayner-secures-fda-approval-for-rayone-emv-toric-iol/

2. The United States Food and Drug Administration. Investigational Device Exemption (IDE). Accessed October 15, 2025. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide

3. Joy J. Rayner launches redesign of IOL calculator RayTrace. Published January 20, 2025. Accessed October 15, 2025. https://www.ophthalmologytimes.com/view/rayner-launches-redesign-of-iol-calculator-raytrace