Eye care products developer Alcon has received the US Food and Drug Administration (FDA) 510(k) clearance for Unity Vitreoretinal Cataract System (VCS) and Unity Cataract System (CS).
Unity VCS and Unity CS are Alcon’s proprietary technologies aimed at delivering advanced surgical innovations.
The Unity VCS console, when paired with compatible devices, is designed for anterior segment procedures such as phacoemulsification and cataract removal.
It is also indicated for posterior segment ophthalmic operations, including vitreoretinal surgery.
Additionally, when equipped with the optional laser, the system is intended for photocoagulation procedures and iridotomy and trabeculoplasty procedures.
On the other hand, the Unity CS console, when used with compatible devices, is specifically indicated for anterior segment procedures such as phacoemulsification and cataract removal.
Alcon chief scientific officer and global R&D head Franck Leveiller said: “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.
“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 advance Alcon’s Constellation Vision System for vitreoretinal procedures and the Centurion Vision System with Active Sentry for cataract surgery.
According to Alcon, both offerings are the first to be introduced from its Unity portfolio.
The company is planning to upgrade over 28,000 Centurion and Constellation devices to the Unity platform over the next decade.
Furthermore, Unity VCS and Unity CS expand the Alcon Vision Suite, aimed at enhancing clinic and operating room efficiency while optimising patient care.
The Alcon Vision Suite will expand further with upcoming Unity products in the years ahead, as per the company.
The eye care products developer has conducted investigational advisory wet lab sessions with over 200 surgeons from more than 30 countries to test both offerings.
Following the 510(k) clearance, Alcon is initiating a programme to gather real-world feedback before the commercial launch, which is scheduled for 2025.
Regulatory submissions in markets across the globe will follow later this year, with a CE Mark anticipated in early 2025.
