FDA resumes review of toric implantable contact lens

September 15, 2009

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.

Key Points

Monrovia, CA-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.

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 Barry G. Caldwell, president and chief executive officer of STAAR Surgical.

"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.

Under the terms of the integrity hold, between September 2007 and May, STAAR Surgical retained Promedica International 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.