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.
