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CrystaLens receives first U.S. accommodative IOL approval
ANAHEIM, Calif. — The CrystaLens has become the first accommodative IOL to receive U.S. regulatory approval, according to manufacturer eyeonics. The company announced the Food and Drug Administration’s approval of the lens here on Friday during the American Academy of Ophthalmology meeting.
The CrystaLens model AT-45 accommodative posterior chamber IOL was given regulatory approval, “indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed and is intended to provide near, intermediate and distance vision without spectacles,” according to the approval letter sent by the FDA to eyeonics.
Company executives told Ocular Surgery News the first implantation is expected in the U.S. by the end of next week.