In its inspection in 2014, the US regulator found that the company’s devices are adulterated and were not in conformity with the good manufacturing practice requirements.
In the warning letter, the FDA said there were missing design files for the various models of the Visian implantable lenses.
The company was also warned on insufficient design control records, lack of design risk analysis documentation and inadequate customer complaint management.
Staar Surgical president and CEO Caren Mason said the lifting of the warning letter is the result of a remediation program which addressed the issues raised by the FDA in the 2014 Warning Letter, and included the assessment, remediation and upgrade of all aspects of the company’s quality systems to assure compliance with Quality System Regulations (QSR).
Mason said: “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.”
Staar Surgical designs, develops, manufactures and markets implantable lenses for the eye with companion delivery systems.
The lenses aim to offer visual freedom for patients, decreasing or removing the dependence on glasses or contact lenses.
All of the company’s lenses are foldable, which allows the surgeon to insert them via a small incision.
The company’s lens used in refractive surgery is called an Implantable Collamer Lens, which includes the EVO Visian ICL product line. Staar said over 800,000 Visian ICLs have been implanted so far.
Headquartered in Monrovia, California, Staar markets lenses in more than 75 countries. The company, which employs about 350 people, operates manufacturing plants in Aliso Viejo and Monrovia, both located in California.
