Alcon (NYSE:ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced that UNITY Vitreoretinal Cataract System (VCS) and UNITY Cataract System (CS) have received U.S. Food and Drug Administration (FDA) 510(k) clearance. These innovations are the first to be introduced from Alcon's highly anticipated Unity portfolio.
"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," said Franck Leveiller, Head of Global R&D and Chief Scientific Officer, Alcon. "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 significant workflow efficiencies over Alcon's current market-leading systems, CONSTELLATION Vision System for vitreoretinal procedures and CENTURION Vision System with ACTIVE SENTRY for cataract surgery.
"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," said Steve Charles, MD, FACS, FICS, FASRS. "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 2029.1 There will be approximately 2.2 million vitrectomy procedures in 2024 across the globe.2 Alcon is the global market leader for cataract and retina procedural packs (consumables used in each surgery).2,3
Today, there are more than 28,000 Centurion and Constellation devices in the market that will be targeted for upgrade to the Unity platform over the next decade. In addition to the system, Unity VCS and Unity CS bring first-to-market technologies and consumables that are designed to drive significant benefits for the surgeon, staff and patients.
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.
Unity VCS and Unity CS are the latest innovations from the Alcon Vision Suite—a portfolio of innovative products designed to help Eye Care Professionals increase clinic and OR efficiency, and deliver exceptional patient experiences. The Alcon Vision Suite will continue to grow with cutting-edge Unity products expected to be introduced over the coming years, adding to our market-leading legacy products which will continue to be available and serviceable. Unity VCS and Unity CS will be supported by Alcon's training, product maintenance and Services teams.
Cautionary Note Regarding Forward-Looking Statements