Alcon gets FDA 510(k) clearance for Unity VCS and Unity CS systems

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Alcon today announced that Unity Vitreoretinal Cataract System (VCS) and Unity Cataract System (CS) have received FDA 510(k) clearance.

According to a news release, these systems are the first to be introduced from Alcon’s Unity portfolio. The Unity VCS is indicated for use during anterior segment and posterior segment ophthalmic surgery. In addition, with the optional laser this system is indicated for photocoagulation, iridotomy and trabeculoplasty procedures.¹

The company noted its Unity CS console, when used with compatible devices, is indicated for use during anterior segment ophthalmic surgery.

“At Alcon, we have a long legacy of involving our customers throughout the research and development process to deliver bold innovation in ophthalmology, and we would like to thank those who helped us arrive at today’s milestone,” Franck Leveiller, head of Global R&D and Chief Scientific Officer at Alcon, said in the news release. “We are excited to introduce the next generation of equipment solutions and consumables—in cataract and vitreoretinal surgery—and deliver meaningful impact for Eye Care Professionals and patients.”

Unity VCS and Unity CS introduce workflow efficiencies over the company's current systems, Constellation Vision System for vitreoretinal procedures and Centurion Vision System with Active Sentry for cataract surgery.¹

“I have been closely involved in the development of Unity VCS and Unity CS; this truly innovative system is a significant upgrade of Alcon’s best-in-class technologies,” Steve Charles, MD, FACS, FICS, FASRS, said in the news release. “It is a proud moment to be able to celebrate this clearance.”

Worldwide, there will be an estimated 31 million cataract surgeries in 2024, and that number is expected to increase to 37 million by 2029.² There will be approximately 2.2 million vitrectomy procedures in 2024 across the globe.³ Alcon is the global market leader for cataract and retina procedural packs (consumables used in each surgery).^3,4

Alcon has tested Unity VCS and Unity CS during investigational advisory wet lab sessions with more than 200 highly experienced surgeons from 30+ countries. Now with 510(k) clearance, Alcon will begin a thorough program to secure real-world feedback before commercial launch in 2025. Regulatory submissions will continue later this year in markets across the globe. CE Mark is expected in early 2025.¹

References

1. Alcon’s Latest Equipment Breakthrough Technologies, Unity VCS and Unity CS, Receive U.S. FDA 510(k) Clearance | Alcon.com. www.alcon.com. Published June 24, 2024. Accessed June 24, 2024. https://www.alcon.com/media-release/alcons-latest-equipment-breakthrough-technologies-unity-vcs-and-unity-cs-receive-us

2. IOL Reports | Market Scope. www.market-scope.com. Accessed June 24, 2024. https://www.market-scope.com/pages/reports/iol?page=1

3. Market Scope 2024 Retinal Surgical Device Market Report, 2024.

4. Market Scope 2024 Cataract Surgical Equipment Market Report, 2024.