The FDA will resume scientific review of the STAAR Surgical Co. premarket approval (PMA) application for its toric implantable contact lens ([TICL]; Visian Toric Implantable Collamer Lens) for patients with myopia and astigmatism after removing the "integrity hold" restrictions it put in place in 2007, according to the company.
-The FDA will resume scientific review of the STAAR Surgical Co. premarket approval (PMA) application for its toric implantable contact lens ([TICL]; Visian Toric Implantable Collamer Lens) for patients with myopia and astigmatism after removing the “integrity hold” restrictions it put in place in 2007, according to the company. This application is a supplement to one approved by the FDA in 2005.
"We are very pleased by the FDA's decision to remove the integrity hold,” said Barry G. Caldwell, president and chief executive officer of STAAR Surgical. The action “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 [TICL],” he added.
The removal of the integrity hold requires that an independent, third-party auditor certify as complete, accurate, and reliable all data submitted in any supplement related to the TICL, according to Caldwell. “This same standard will be applied to the next subsequent submission for a 510(k), [investigational device exemption], or PMA sent to the FDA by the company,” he said.
“We believe the outstanding clinical results with this technology are evidenced by the [TICL’s] data,” Caldwell continued, noting that the lens has been implanted more than 27,000 times outside the United States.
Under the terms of the integrity hold, between September 2007 and May, STAAR Surgical retained Promedica International (PMI) to perform comprehensive systems and data audits related to the application, including audits of all patient-record data at all seven clinical sites and a systems audit of the company. Based on these reports, STAAR Surgical submitted a corrective action plan to the FDA in May to address the audit-report findings and provide assurances that all future studies would be conducted according to applicable laws, regulations, and good clinical practices.
“We appreciate the guidance from PMI and the FDA in our efforts to identify and correct any actions or processes that help assure the integrity of all clinical data collected by the company,” Caldwell said. "We believe we have made good progress and remain committed to continuously improve all quality and regulatory systems and processes.”