FDA Clears Rayner's Sophi Wireless Phacoemulsification System for U.S. Cataract Surgery Market
核心洞察
The FDA has granted 510(k) clearance to Rayner's Sophi phacoemulsification system, marking the first battery-based, wireless phaco system available for U.S. cataract surgeons.
The system features triple pump fluidics technology with IOP control, peristaltic, and Clean Venturi pumps designed to enhance anterior chamber stability and reduce contamination during cataract surgery.
Sophi's sustainable design includes reusable cassettes for up to 10 procedures and uses 75% less plastic than standard phaco machines, potentially reducing 307 kg of discarded plastic per 1,000 surgeries.
Rayner, a British ophthalmic medical device manufacturer, has received FDA 510(k) clearance for its Sophi (Swiss Ophthalmology Innovation) phacoemulsification system, introducing the first battery-based, wireless phaco platform to the U.S. cataract surgery market. The system is now commercially available for use in ambulatory surgical centers, office-based practices, and hospital networks across the United States.
Revolutionary Wireless Technology
The Sophi system represents a significant departure from conventional phacoemulsification technology through its wireless design and battery-based operation. The platform was originally developed by This AG (搜索), a Swiss-based medical manufacturing company that Rayner acquired in early 2024, marking the company's second FDA clearance in less than three months following approval of the RayOne EMV Toric IOL in October 2025.
The system's core innovation lies in its "triple pump fluidics" technology, consisting of three specialized pumps working in concert. The IOP control pump actively manages intraocular pressure and infusion to enable more stable chamber dynamics during surgery. A peristaltic pump controls aspiration flow and vacuum, while a Clean Venturi pump protects against contamination by the patient's eye fluids.
Enhanced Surgical Efficiency and Safety
Rayner designed the Sophi system around three fundamental pillars: mobility, simplicity, and safety. The wireless operation eliminates the typical bulkiness associated with external compressors through integrated compressors for vitrectomy and Clean Venturi functions. This lean design provides surgeons with high flexibility and ease of handling in the operating room.
The system features a Cassette Slot-In System that eases handling during surgery preparation and prevents potential contamination from non-sterile devices during sterile cassette insertion. The multi-use cassette automatically recognizes the transition between air and infusion liquids and can be reused for up to 10 procedures, significantly reducing waste and material use.
Additional features include a speedy system start-up process with customizable multi-surgeon settings, a 180° rotatable 19-inch display with adjustable tray position, and an intuitive graphical user interface. The platform incorporates a sinusoidal signal-controlled handpiece designed for reduced energy and increased eye protection, along with Bluetooth connectivity for transmitting live microscopic images to displays via WiFi.
Sustainability Impact
The Sophi system addresses growing environmental concerns in healthcare through its sustainable design approach. According to a multisociety position paper produced in collaboration with major ophthalmology organizations including the American Society of Cataract and Refractive Surgery and the European Society of Cataract and Refractive Surgeons, the system's day cassette option could reduce discarded plastic by 307 kg per 1,000 cataract surgeries.
The platform uses 75% less plastic than standard phaco machines and features cassette packaging that is 19% lighter than conventional alternatives. This sustainability focus aligns with initiatives from EyeSustain, a global coalition representing 55 ophthalmology societies working to advance sustainability in eye care through education, research, innovation, and advocacy.
Market Positioning and Availability
"US surgeons deserve an innovative alternative to conventional phaco technology, and Sophi delivers that," stated Tim Clover, chief executive officer of Rayner. "Clinics worldwide tell us they're running more efficiently and cutting costs and waste, so we're looking forward to bringing these benefits to surgeons across the US through our new team of surgical equipment specialists."
While the system has just received FDA clearance in the United States, it has been commercially available in other countries and regions globally. The clearance represents a significant milestone for Rayner, which has demonstrated strong momentum in the U.S. market with recent achievements including completion of patient enrollment for its AI-developed RayOne Galaxy spiralized IOL study in February 2025.
The Sophi system's introduction to the U.S. market provides cataract surgeons with a technologically advanced alternative that combines wireless operation, enhanced safety features, and environmental sustainability in a single platform designed to improve surgical efficiency and patient outcomes.