Rayner, a British ophthalmic medical product manufacturer, announced that the FDA has granted 510(k) clearance to its Sophi (Swiss Ophthalmology Innovation) phacoemulsification system.
First, a look at Rayner.
With its U.S. headquarters in Memphis, Tennessee, the global manufacturing company specializes in intraocular lenses (IOLs) and ophthalmic viscosurgical devices (OVDs).
In fact (in recent news), Rayner reported two major U.S. achievements:
- February 2025: Patient enrollment completion in a U.S.-based study evaluated its artificial intelligence-developed RayOne Galaxy, the first-ever spiralized IOL.
- October 2025: FDA approval of the RayOne EMV (enhanced monofocal vision) Toric IOL.
And now the company has secured its second FDA clearance in less than 3 months.
Indeed it has. And also keep in mind: this system wasn’t originally developed by Rayner.
The company actually acquired the Sophi system through its acquisition of This AG, a Swiss-based medical manufacturing company, in early 2024.
- This AG was the original developer of the phaco system.
Gotcha. Well, let’s talk about the system.
What it is: The first battery-based, wireless phaco system designed to offer more control of anterior chamber stability during cataract surgery by emulsifying and aspirating the opacified lens (natural cataract).
Key to its functionality: Is Sophi’s utilization of a “triple pump fluidics” system consisting of:
- Intraocular pressure (IOP) control pump for actively managing IOP and infusion (enabling a more stable chamber dynamic)
- Peristaltic pump for controlling aspiration flow and vacuum
- Clean venturi pump for protecting against contamination by the patient’s eye fluids
Check out page 16 of the system’s product brochure for more details on each pump—and check out its complete safety system.
And how does it offer increased efficiency?
Described as a “high-end” phaco system, its design was constructed with a three-pillar concept in mind to enable a simpler and faster operating procedure.
- Mobility: Offers surgeons high flexibility to increase usability and ease of handling in the operating room (OR).
- Simplicity: Designed for straightforward operation and easy user handling to save time and increase productivity.
- Safety: Enabled by the Clean Venturi pump and automated Cassette Slot-In System reducing contamination as well as the IOP control pump promoting high chamber stability.
- Take note: The Cassette Slot-In-System eases handling during surgery prep and prevents an assistant’s potential contamination from the non-sterile device during sterile cassette insertion.
Go on …
Speaking of that Cassette Slot-In-System: This multi-use cassette also allows the system to automatically recognize the transition between air and infusion liquids within the cassette.
Additionally, it is reportedly:
- Reusable for up to 10 procedures (reducing waste and material use).
- Is 19% lighter on single-use punch packaging than conventional alternatives
- Uses 75% less plastic than standard phaco machines
And as a bonus: Click here to hear real-world insights from two surgeons utilizing the Sophi system in their ORs.
So! What features are included in this system?
In addition to its wireless operations, Sophi’s integrated compressors (for vitrectomy and Clean Venturi) give the system a lean design by eliminating the typical bulkiness associated with external compressors.
A few other noteworthy design components and capabilities:
- Speedy system start-up process with customizable multi-surgeon settings
- A 180° rotatable, 19-inch display and adjustable tray position
- Includes an intuitive graphical user interface
- Integrated ergonomic handle for all-side mobility and flexibility via a mono-brake system
- Sinusoidal signal-controlled handpiece for reduced energy and increased eye protection
- Bluetooth connection for surgeons to transmit live microscopic images to a display (via WiFi)
- Foot pedal with integrated light-emitting diode (LED) lighting
- Sensory information assistance via verbal Text2Speech with color-changing LED projection
Editor’s note: The above features are based on the system’s global availability. Not all components / functions may be available in the U.S.; contact Rayner to confirm.
An impressive list … now let’s talk availability.
While the system has only just received FDA clearance in the United States, it’s reportedly already commercially available in other countries and regions across the globe.
See here for a look.
And in the U.S.?
The system is now also available for commercial use.
Rayner advises customers interested in purchasing Sophi to reach out to their local Rayner representative for more details.