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Staar’s Visian TICL requires FDA panel review

This article was originally published in The Gray Sheet

Executive Summary

PMA supplement for Staar Surgical's Visian TICL toric implantable Collamer lens for treating myopia and astigmatism will require review by the agency's Ophthalmic Devices Panel, contrary to the firm's expectations. As a result, FDA approval will now be "unlikely in 2007, as previously anticipated," Staar says Feb. 6. The panel is needed since Visian TICL is "the first toric phakic implantable lens to be reviewed," according to the company. The supplement, submitted last April, references a December 2005 PMA approval for Staar's Visian ICL for myopia. FDA had asked Staar to amend the Visian TICL supplement last November (1"The Gray Sheet" Dec. 4, 2006, In Brief)...
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