Alcon’s Unity Vitreoretinal Cataract System (VCS) and Unity Cataract System (CS) have received United States Food and Drug Administration (FDA) 510(k) clearance. The innovative systems are the first to be introduced from Alcon’s new Unity portfolio, with more products anticipated in the coming years.
According to a statement from Alcon, 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”.1
Additionally, 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 over 30 countries. Now with 510(k) clearance, Alcon stated that it 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.
References
- Alcon’s Latest Equipment Breakthrough Technologies, Unity VCS and Unity CS, Receive U.S. FDA 510(k) clearance, media release 24 June 2024. alcon.com/media-release/alcons-latest-equipment-breakthrough-technologies-unity-vcs-and-unity-cs-receive-us.
- Market Scope 2024 IOL Market Report, 2024.
- Market Scope 2024 Retinal Surgical Device Market Report, 2024.
