STAAR Surgical Company has been informed by the US FDA Division of Bioresearch Monitoring that the restrictions of the “integrity hold” put in place on August 3, 2007 have been removed. The integrity hold removal enables FDA to resume scientific review of the STAAR application for the Toric Implantable Collamer Lens (TICL) for Myopic/Astigmatic patients. This STAAR application is a PMA Supplement to the Visian ICL that was approved by the FDA on December 22, 2005.
We are very pleased by the FDA’s decision to remove the integrity hold. This very important step in the process is not to be construed as approval of any conditions that may be found in the future, nor should it be construed as clearance to market the Visian Toric ICL, stated Barry G. Caldwell, President &Chief Executive Officer of STAAR Surgical. The removal does require that any supplement related to the Visian Toric ICL be audited and contain a certification from an independent third party auditor that all data in submission is complete, accurate and reliable. This same standard will be applied to the next subsequent submission for a 510(k), IDE or PMA sent to the FDA by the Company. We believe the outstanding clinical results with this technology are evidenced by the Visian Toric ICL’s data. Additional evidence is the acceptance of the technology as more than 150,000 Visian ICLs have been implanted worldwide, of which more than 27,000 have been Visian Toric ICLs outside the US. The Visian Toric ICL corrects both myopia and astigmatism with the same procedure, added Mr. Caldwell.