Alcon’s latest equipment breakthrough technologies, Unity VCS and Unity CS, receive US FDA 510(k) clearance

Swiss firm Alcon, the global leader in eye care, has announced that UNITY^® Vitreoretinal Cataract System (VCS) and UNITY^® Cataract System (CS) have received US Food and Drug Administration (FDA) 510(k) clearance. These innovations are the first to be introduced from Alcon’s highly anticipated Unity portfolio.

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.

Worldwide, there will be an estimated 31 million cataract surgeries in 2024, and that number is expected to increase to 37 million by 2029. There will be approximately 2.2 million vitrectomy procedures in 2024 across the globe.

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.