Sam Brusco, Associate Editor06.24.24
Alcon has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Unity vitreoretinal cataract system (VCS) and Unity cataract system (CS). They are the first introductions to Alcon’s Unity portfolio.
The company said the two new systems debut workflow efficiencies over its current Constellation vision system for vitreoretinal procedures and Centurion vision system with Active Sentry for cataract surgery. There are over 28,000 Centurion and Constellation devices targeted for upgrade to the Unity platform over the next decade.
The Unity VCS console is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy and trabeculoplasty procedures.
The Unity CS console is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery.
Alcon tested Unity VCS and Unity CS during investigational advisory wet lab sessions with over 200 highly experienced surgeons from 30+ countries. The company intends to secure real-world feedback before commercial launch in 2025. CE mark approval is also expected in 2025.
The company plans to introduce new Unity products in the coming years.
“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 R&D and Chief Scientific Officer, Alcon. “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.”
The company said the two new systems debut workflow efficiencies over its current Constellation vision system for vitreoretinal procedures and Centurion vision system with Active Sentry for cataract surgery. There are over 28,000 Centurion and Constellation devices targeted for upgrade to the Unity platform over the next decade.
The Unity VCS console is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy and trabeculoplasty procedures.
The Unity CS console is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery.
Alcon tested Unity VCS and Unity CS during investigational advisory wet lab sessions with over 200 highly experienced surgeons from 30+ countries. The company intends to secure real-world feedback before commercial launch in 2025. CE mark approval is also expected in 2025.
The company plans to introduce new Unity products in the coming years.
“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 R&D and Chief Scientific Officer, Alcon. “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.”