FDA clears Alcon’s Unity cataract system, Unity vitreoretinal cataract system
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The FDA granted 510(k) clearance to Alcon’s Unity combined vitreoretinal cataract system and stand-alone cataract system, according to a press release.
The company said the systems provide workflow efficiencies over its current Constellation vision system for vitreoretinal surgery and Centurian vision system for cataract surgery.
Alcon will begin to collect real-world user experience in the U.S. before commercial launch in 2025.
“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,” Franck Leveiller, head of global R&D and chief scientific officer at Alcon, said in the release. “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.”