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Alcon Says Unity Vitreoretinal Cataract, Cataract Systems Get FDA Clearance
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Alcon Says Unity Vitreoretinal Cataract, Cataract Systems Get FDA Clearance
Jun 24, 2024 9:03 AM

11:41 AM EDT, 06/24/2024 (MT Newswires) -- Alcon ( ALC ) said Monday its Unity vitreoretinal cataract system and Unity cataract system have received the US Food and Drug Administration's 510(k) clearance.

The company said it tested the systems during investigational advisory wet lab sessions with surgeons from more than 30 countries and will now start a thorough program to secure real-world feedback in the US before commercial launch in 2025.

Regulatory submissions will continue later in 2024 in markets globally and CE Mark is expected in early 2025, the company added.

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