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FDA request may delay launch of Tecnis multifocal IOL

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SANTA ANA, Calif. — The Food and Drug Administration has recommended that Advanced Medical Optics expand enrollment in its U.S. clinical study of the Tecnis multifocal IOL, the company announced in a press release.

The FDA's request could delay the IOL's U.S. launch by 12 to 18 months, according to AMO. The company had hoped to launch the product in the first half of 2008, and company officials still plan to submit a premarket approval application for the IOL next month in accordance with that launch date, according to the release.

The delay is related not to data from the trial, but to "sample size assumptions" in the study protocols established in the investigational device exemption application for the IOL, said Leonard Borrmanm, PharmD, AMO vice president of research and development, in the release.