FDA Clears Alcon's Unity Vitreoretinal-Cataract System and Standalone Cataract System

Alcon announced that its Unity Vitreoretinal Cataract System (VCS) and Unity Cataract System (CS) have received FDA 510(k) clearance. The new devices are the first to be introduced from Alcon’s Unity portfolio and represent Alcon's next generation of equipment solutions and consumables in cataract and vitreoretinal surgery. 

According to Alcon, the Unity VCS and Unity CS introduce workflow efficiencies over Alcon’s current systems, Constellation Vision System for vitreoretinal procedures and Centurion Vision System with Active Sentry for cataract surgery.

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, according to Alcon. 

Alcon said it has tested the Unity VCS and Unity CS during investigational advisory wet lab sessions with more than 200 surgeons from 30+ countries. Now with 510(k) clearance, Alcon will begin a 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 will be part of the Alcon Vision Suite portfolio. The devices will be supported by Alcon’s training, product maintenance and services teams.