GENEVA—Alcon (SIX/NYSE: ALC), a global eyecare company with a portfolio of both surgical and vision care products, has announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Unity Vitreoretinal Cataract System (VCS) and Unity Cataract System (CS), the first products to be introduced from Alcon’s Unity portfolio. “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,” said Franck Leveiller, head of global research and development and chief scientific officer at Alcon.

“We are excited to introduce the next generation of equipment solutions and consumables in cataract and vitreoretinal surgery and deliver meaningful impact for eyecare professionals and patients,” Leveiller said.

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

“I have been closely involved in the development of Unity VCS and Unity CS. This truly innovative system is a significant upgrade of Alcon’s best-in-class technologies,” said Steve Charles, MD, FACS, FICS, FASRS. “It is a proud moment to be able to celebrate this clearance.”

In 2024, the company estimates there will be an estimated 31 million cataract surgeries. This number is expected to increase to 37 million by 2029. Furthermore, there will be approximately 2.2 million vitrectomy procedures in 2024 across the globe. In addition, the company estimates that there are more than 28,000 Centurion and Constellation devices on the market that will be targeted for an upgrade to the Unity platform over the next decade. 

Alcon noted that it has tested Unity VCS and Unity CS during investigational advisory wet lab sessions with more than 200 surgeons from more than 30 countries. With 510(k) clearance, the company added, it can 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 marking is expected in early 2025.