Rayner announced the simultaneous FDA approval and U.S. commercial launch of RayOne Galaxy and RayOne Galaxy Toric, an artificial intelligence (AI)-developed spiral intraocular (IOL) platform.
And if you’re keeping track: This marks the second U.S. regulatory clearance the British ophthalmic manufacturer has received this year.
Hold up — didn’t RayOne already receive regulatory approval?
You must be thinking of the RayOne EMV Toric IOL, which was granted FDA approval in October 2025 (our coverage on that here).
Outside of the U.S., however: Since making their international debut in 2024, the RayOne Galaxy and RayOne Galaxy Toric have already received regulatory approval in a reported 75 countries.
- The most recent numbers: over 200K implantations
And now they’re in the U.S.
At long last, yes. The FDA’s approval of this first-ever spiralized IOL platform is in large part due to the positive results from an investigational device exemption (IDE) study.
But more details on that later.
So! Tell me about this platform.
The RayOne Galaxy platform consists of two fully preloaded IOLs with a spiral design—a first for an IOL—developed with a proprietary artificial intelligence (AI) engine trained on patient outcomes.
Rayner says the non-diffractive spiral optic provides optimized visual acuity (VA) while delivering:
- Full range of continuous vision from +0.5 D to –2.5 D
- Binocular defocus VA of ≥ 0.2 logMAR across ~4.0 D
- Less halo and minimized dysphotopsia
- No loss of transmitted light
- Toric power options (cylinder +1.5 D to +3.75 D [0.75 D increments])
And what are these IOLs made of?
A single piece of Rayner's patented Rayacryl hydrophilic acrylic, a copolymer of hydrophilic and hydrophobic methacrylates.
The material is soft and easy to handle, vacuole-free, and associated with low inflammatory response. And its refractive index is lower than that of hydrophobic acrylic IOLs.
Other specs include:
- 26% water content at equilibrium
- A benzophenone ultraviolet (UV)A-absorbing agent (UV 10% cut-off at 380 nm)
See here for the full technical specifications.
Where does this spiral design factor in?
As we previously reported, a similar spiral IOL concept was the subject of research published in Optica in early 2024.
- Notably: While that study hasn't been confirmed to involve Rayner's lens, it details how the design works and how it performed.
And compared to trifocals: Rayner says the Galaxy has a smooth optic surface with no surface steps, discontinuities, or discrete annular zones.
Got it. Speaking of studies … what do we know about its IDE performance?
That trial collected safety and effectiveness data on the RayOne Galaxy IOL platform in over 250 patients across 10 U.S. clinical sites.
Per Rayner: The results showed a strong safety profile, with patient-reported outcomes demonstrating low levels of dysphotopsia—referred to as a “key differentiator compared with established presbyopia-correcting IOLs.”
- Click here for a look at those four other brands (and their performance).
To note: A full data readout on the IDE study is currently not publicly available.
How about from other (non-U.S.) evaluations?
A pre-launch clinical evaluation conducted on the IOL platform also led to positive postoperative clinical outcomes. See those details here.
In fact: A full rundown on the IOL’s performance can be viewed here, as presented during the 2024 European Society of Cataract and Refractive Surgeons (ESCRS) symposium.
Now to the big question: How can surgeons get a hold of this system?
The IOL platform will be featured at the Rayner booth (#4119) during the American Academy of Ophthalmology (AAO) annual meeting in New Orleans, Louisiana (Oct. 9-12).
- Surgeons are invited to stop by to get a look.
Otherwise: Reach out to a local Rayner representative for details on adding the Galaxy system to your surgical arsenal.