FDA Approves First Spiral-Optic Presbyopia Lens

RayOne GalaxyWhat to know

30-second read

For Ophthalmology

Who

Adults having cataract surgery who want presbyopia correction with a lower reported risk of night glare and halo. Not for patients happy with monofocal, distance-only correction.

What it does

A non-diffractive spiral-optic IOL adding +1.5 D intermediate and +3.0 D near power for a continuous range of focus; the Toric model also reduces residual astigmatism.

Evidence

FDA’s approval rests on a 250+-patient, 10-site IDE trial. Company tests report less glare and halo than diffractive trifocals; pivotal results are not yet public.

What’s different

A continuous spiral surface instead of concentric diffractive rings — a third optical mechanism in the premium-IOL category, not a variation on the first two.

Key consideration

A premium, largely out-of-pocket lens. Ask specifically for bothersome glare/halo rates, not just any awareness of them, before counseling a patient.

Availability

FDA approved 24 September 2026 (PMA supplement P060011/S045); commercially available now. Rayner reports 200,000+ implants across 75 countries since its 2024 international launch.

Practice impactConsider for selected patients

A new entry in the premium-IOL conversation for patients who want a fuller range of vision but are wary of trifocal night glare — not a reason to change technique, and not yet backed by independently published U.S. pivotal-trial data.

Read the full physician analysis

Full analysis · 9 min readFDA premarket approval letter, P060011/S045 · Journal of Refractive Surgery (2025) · CMS Ruling 05-01

The FDA approved a non-diffractive, spiral-optic intraocular lens for presbyopia after cataract surgery on 24 September 2026, giving cataract surgeons a third optic family alongside diffractive trifocals and extended-depth-of-focus (EDOF) lenses. RayOne Galaxy and its toric counterpart, RayOne Galaxy Toric, are built by Rayner, the UK lens manufacturer that made the first intraocular lens ever implanted, in 1949. The lenses are approved to improve intermediate and near visual acuity while keeping distance acuity comparable to a monofocal IOL — a premium-IOL upgrade a growing share of cataract patients ask for by name — on the strength of a 250-plus-patient U.S. trial and, Rayner says, more than 200,000 implants abroad since 2024.

A third optic design enters a two-design market

Presbyopia-correcting cataract surgery has, for more than a decade, come down to two optical strategies. A diffractive trifocal lens splits incoming light across three focal points using concentric rings etched into the lens surface, built for distance, intermediate and near vision at once; it delivers strong near vision but can produce halos and starbursts around headlights and streetlights at night, because the diffractive rings are designed to redirect some light away from the eye’s dominant focus to create the additional focal points. An extended-depth-of-focus, or EDOF, lens instead stretches a single focal point into a longer, shallower range, trading some near-vision strength for fewer reported dysphotopsias. Surgeons and patients have mostly been choosing between those two trade-offs since trifocals reached the U.S. market.

RayOne Galaxy and RayOne Galaxy Toric, approved under premarket approval supplement P060011/S045, are built on a different premise. Rayner describes the optic as non-diffractive and spiral: rather than concentric rings, the lens surface varies continuously along a rotational profile, adding +1.5 D of intermediate power and +3.0 D of near power at the IOL plane without the discrete diffractive steps that scatter light into halos. Rayner says the design carries no loss of transmitted light to spectral splitting, a property it says a diffractive optic cannot claim by its very construction. That is the company’s framing of its own mechanism; FDA’s approval covers the visual-acuity indication, not an independent verdict on comparative glare and halo, which is addressed below.

What the U.S. trial shows, and what it does not

FDA’s approval rests on a prospective, multicenter, randomized, masked, active-controlled investigational device exemption (IDE) trial that enrolled more than 250 patients across 10 U.S. sites, with enrollment completed in February 2025. The agency’s approval letter and summary of safety and effectiveness data describe the indication for both models as improving intermediate and near visual acuity while keeping distance visual acuity comparable to a monofocal IOL. As of this approval, Rayner has not published the pivotal U.S. trial’s detailed visual-acuity or dysphotopsia results in a form Regulatory News could independently examine.

Independent of the pivotal trial, a peer-reviewed report in the Journal of Refractive Surgery in 2025 described outcomes from the lens’s earlier international use, and a separate 2025 analysis examined how range of vision and optical performance vary with pupil size. Company-sponsored abstracts presented at the European Society of Cataract and Refractive Surgeons’ 2025 congress reported better near visual acuity than two competing presbyopia-correcting IOLs at a single study site, and good distance, intermediate and near vision at three months in a toric cohort. None of that is the U.S. pivotal data FDA actually reviewed, and none of it has so far appeared in an independent, non-company-sponsored publication.

Where a spiral optic sits among premium IOLs

	RayOne Galaxy (spiral)	Diffractive trifocal	EDOF	Monofocal
U.S. status	Approved 24 Sep 2026; commercially available now	Multiple products marketed since 2019	Multiple products marketed since 2014	Marketed for decades; Medicare-covered
Optical mechanism	Continuous non-diffractive spiral surface	Concentric diffractive rings, 3 focal points	Single elongated focal zone	Single fixed focal point
Near add power	+3.0 D at the IOL plane	Typically +3.0 to +4.0 D, product-dependent	Little to none by design	None
Reported night dysphotopsia	Company-sponsored bench tests report less than trifocal; no independent U.S. data yet	Most common complaint driving explantation in this category	Lower than trifocal; some blur acknowledged	Lowest of the group
Astigmatism correction	Toric model only (RayOne Galaxy Toric)	Toric versions available from most makers	Toric versions available from most makers	Toric versions available
Medicare/payer coverage	Premium add-on not covered (CMS Ruling 05-01)	Premium add-on not covered (CMS Ruling 05-01)	Premium add-on not covered (CMS Ruling 05-01)	Standard IOL and surgery covered

Diffractive trifocal and EDOF particulars are generalized across the category, not any single competing product; prescribe and counsel from each lens’s own labeling, not this table.

Patient selection: who fits the label

Both models are intended for adults whose cataractous natural lens has been removed and who are having the IOL implanted in the capsular bag — standard phacoemulsification cataract surgery, not a distinct procedure. The base RayOne Galaxy (model RAO605G) is intended for eyes with less than 1.00 diopter of pre-existing corneal astigmatism; outside that range, the label points toward the toric model instead. RayOne Galaxy Toric (model RAO615X) adds a toric posterior surface to reduce residual refractive astigmatism; trade-press summaries of the approval describe a cylinder power range at the lens, but Regulatory News has not independently confirmed the complete cylinder table against FDA’s published labeling, and prescribers should verify it directly before use.

As with any premium presbyopia-correcting lens, the selection conversation is as much about expectations as about biometry: patients should understand before surgery that the premium function is an elective, largely self-funded upgrade over a standard monofocal lens, and that no presbyopia-correcting IOL, spiral or diffractive, eliminates every compromise of fixed-focus optics.

Glare and halo: the number worth asking for

The headline claim behind a non-diffractive design is fewer dysphotopsias — the halos, starbursts and glare that are the most common reason patients regret a premium lens. Rayner’s own reporting describes “low levels of bothersome dysphotopsia” and cites a company-sponsored bench comparison in which the spiral optic produced significantly less halo and glare than Rayner’s own diffractive trifocal, with most participants preferring it across distances. Separately, at least one trade-press account of the lens’s results cites a figure near 49% of patients reporting dysphotopsia to some degree.

Those two figures are not necessarily in conflict — any awareness of a visual phenomenon and a phenomenon being bothersome enough to affect satisfaction or drive explantation are different endpoints, and the diffractive-trifocal literature shows the same split. The practical takeaway for counseling is to ask Rayner’s representatives, and look for in the eventual published pivotal data, the bothersome or need-to-remove dysphotopsia rate specifically, not a bare percentage of patients who notice any night-vision artifact at all. Until the U.S. pivotal results are independently published, comparative glare and halo claims for RayOne Galaxy should be treated as company-reported, not FDA-adjudicated.

What it costs, and who pays

FDA approval is a statement about safety and effectiveness, not a coverage decision, and the two are governed separately here. Standard cataract surgery with a conventional monofocal IOL is a covered Medicare Part B benefit. Under CMS Ruling 05-01 (May 2005) and its 2007 companion, CMS-1536-R, the presbyopia-correcting function of a premium IOL is treated as outside Medicare’s benefit category — conceptually similar to eyeglasses or contact lenses, which Medicare also does not cover — so the beneficiary pays the difference between the premium lens and associated service charges and what conventional cataract surgery would have cost. Commercial payers generally apply the same logic to the refractive add-on. Rayner has not published U.S. list pricing for RayOne Galaxy; premium-IOL upgrades across the category have typically run in the range of roughly $1,500 to $3,000 per eye out of pocket, a category-wide figure rather than one specific to this lens.

Where this fits in the clinic

• No new technique or equipment. Implantation uses the same phacoemulsification and capsular-bag placement as any other IOL; surgeons already offering premium lenses need no new instrumentation for the non-toric model.
• A third shelf in the premium-IOL conversation. A plausible fit for patients who want fuller near and intermediate vision than an EDOF lens provides but are wary of a trifocal’s reported night-glare risk — pending independent confirmation that the trade-off is real at scale.
• Toric workflow for astigmatism. RayOne Galaxy Toric needs the same toric power calculation and axis-marking workflow any toric IOL requires; it is not a drop-in replacement for the non-toric model in eyes with meaningful corneal astigmatism.
• Thin independent track record in the U.S. Two and a half years of international use and a single 250-plus-patient U.S. trial is a real but still limited evidence base next to trifocal and EDOF categories with years more U.S. follow-up; adopting early means counseling patients honestly about that.
• Not a reason to convert a monofocal-only practice, and not a reason to revisit a patient who is already happy with a different premium lens.
• Coverage conversation stays the same as for any other premium IOL: confirm self-pay expectations before surgery, not after.

How RayOne Galaxy got here, and what is next

1. 2024

   International launch

   Rayner launches RayOne Galaxy outside the U.S.; the company reports regulatory approval eventually reached in 75 countries.

2. Feb 2025

   U.S. IDE enrollment completes

   More than 250 patients enrolled across 10 U.S. sites in the pivotal investigational device exemption trial.

3. 2025

   International data published

   Journal of Refractive Surgery reports outcomes from the lens’s earlier non-U.S. use; a separate paper examines range of vision by pupil size.

4. 12 Feb 2026

   PMA supplement filed

   Rayner files premarket approval supplement P060011/S045 with FDA, amended 26 June 2026.

5. 24 Sep 2026

   FDA approves RayOne Galaxy and Toric

   Both models cleared for U.S. commercial sale; first U.S. implantations and launch reported in early October.

6. Q4 2026

   RayOne Galaxy Hydrophobic (outside the U.S.)

   A hydrophobic version of the platform is planned for CE-marked countries, with 12-month multicenter data to follow; no U.S. filing has been announced.

Frequently asked questions

Is RayOne Galaxy covered by Medicare?

Standard cataract surgery with a conventional monofocal lens is a covered Medicare Part B benefit. Under CMS Ruling 05-01 (2005) and CMS-1536-R (2007), the presbyopia-correcting function of a premium IOL like RayOne Galaxy is not a covered benefit; the beneficiary pays the difference between the premium lens and service charge and what conventional cataract surgery would have cost. Rayner has not published U.S. list pricing.

How does a spiral optic differ from a diffractive trifocal lens?

A diffractive trifocal splits light across three focal points using concentric etched rings, which by design redirect some light away from the eye's dominant focus and can produce halos or starbursts at night. Rayner's spiral optic varies continuously along a rotational profile instead of using rings, which the company says avoids that designed-in light loss. FDA's approval covers the lens's visual-acuity indication; it does not independently adjudicate Rayner's glare and halo comparisons, which come from company-sponsored bench testing and conference abstracts.

Can RayOne Galaxy correct astigmatism?

The base RayOne Galaxy (model RAO605G) is intended for eyes with less than 1.00 diopter of pre-existing corneal astigmatism. RayOne Galaxy Toric (model RAO615X) adds a toric posterior surface to reduce residual refractive astigmatism; trade-press summaries of the approval describe a cylinder power range, but Regulatory News has not independently confirmed the full cylinder table against FDA's published labeling.