STAAR Surgical Provides Update on Toric ICL Application With FDA
MONROVIA, Calif., Feb. 6 /PRNewswire-FirstCall/ -- STAAR Surgical Company today provided an update on the status of the Company's submission to the U.S. Food and Drug Administration (FDA) for approval of its Visian TICL(TM), a toric implantable Collamer(R) lens designed to treat both myopia and astigmatism. STAAR announced that its representatives met with the staff of the FDA Office of Device Evaluation on January 31, 2007 to discuss the FDA's comments on STAAR's Supplemental Premarket Approval application for the TICL received by letter on November 20, 2006. At the meeting, the FDA staff indicated that, because the TICL is the first toric phakic implantable lens to be reviewed, STAAR's amended application for the TICL would be submitted to the Ophthalmic Devices Panel of the Center for Devices and Radiological Health for evaluation.