Alcon announced that UNITY Vitreoretinal Cataract System (VCS) and UNITY Cataract System (CS), a standalone cataract system, have received FDA 510(k) clearance. These solutions are the first to be introduced from Alcon’s Unity portfolio of surgical equipment. Unity VCS and Unity CS introduce significant workflow efficiencies over Alcon’s current systems, CONSTELLATION Vision System for vitreoretinal procedures and CENTURION Vision System with ACTIVE SENTRY for cataract surgery, the company said in a press release.

Alcon said it 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, the company said 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.

Unity VCS and Unity CS are the latest innovations from the Alcon Vision Suite — a portfolio of products designed to help physicians increase clinic and OR efficiency. The Alcon Vision Suite will continue to grow with Unity products expected to be introduced over the coming years, adding to the company’s 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.

The company also said that existing Centurion and Constellation devices in the market will be targeted for upgrade to the Unity platform over the next decade.