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The FDA has approved the marketing of an accommodating IOL (Crystalens AO, Bausch + Lomb) in quarter-diopter steps in the United States.
Aliso Viejo, CA
-The FDA has approved the marketing of an accommodating IOL (Crystalens AO, Bausch + Lomb) in quarter-diopter steps in the United States.
The company began shipping the lens in the additional diopter steps in mid-May.
The FDA first approved this implant in 2003, and it remains the only FDA-approved accommodating lens. The IOL, now in its fifth generation, also recently received new technology IOL (NTIOL) status from the Centers for Medicare and Medicaid Services.
Quarter-diopter steps are available for two models of the lens (AT50AO, AT52AO), in the ranges of 18 to 22 D. A wider dioptric range should be available by the end of the year, according to the company.
"Quarter-diopter steps for the Crystalens Five-0 and HD have been enthusiastically accepted by surgeons, so we have now added them to the AO model," said Tom Frinzi, vice president of global commercial operations, Bausch + Lomb Surgical. "We still remain the only presbyopic channel lenses available in the United States in quarter-diopter steps and the only presbyopic lens with NTIOL status."