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FDA lifts warning letter against STAAR Surgical

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The FDA has issued a close-out letter to STAAR Surgical, lifting a 2014 warning regarding the manufacture of Visian Implantable Collamer Lens devices, the company announced in a press release.

The FDA action is a result of “a comprehensive remediation program” that addresses the issues raised by the FDA and includes “assessment, remediation and upgrade of all aspects of STAAR’s quality systems to assure compliance with Quality System Regulations (QSR),” Caren Mason, president and CEO of STAAR, said.

The initial warning letter, issued May 21, 2014, listed multiple failures regarding design controls, documentation, procedures and design transfers.

“We have steadfastly initiated and promoted a culture of quality, which emphasizes prevention and accountability throughout the organization. We are committed to continuing and strengthening this companywide emphasis on excellence,” Mason said in the release.