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FDA requests additional information from STAAR on toric ICL

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MONROVIA, Calif. — The U.S. Food and Drug Administration has requested additional information and data analysis from STAAR Surgical Co. to complete its review of the Visian TICL, a toric version of the company's Visian ICL, according to a STAAR press release.

The FDA has also requested additional data on the transitory rise in the rate of excessive ICL vaulting that STAAR reported earlier this year, a company official said in the release. The review period could be extended by up to 180 days after STAAR submits the new information, according to the release.

The Visian TICL, which is indicated for the correction of myopia and astigmatism, is currently sold in Europe and some Asian countries, according to the release.