In late 2009, Lenstec completed a full FDA manufacturing inspection for both our first two IOLs (The Tetraflex Active Lifestyle™ IOL & the Softec HD™ Bi-Aspheric Quarter Diopter IOL). Following completion of the manufacturing inspection, we achieved our first FDA PMA Approval for the Softec HD lens in April of 2010. We then submitted for, and achieved, our 2nd FDA PMA Approval for the Softec 1 in June of 2010.
Documentation
Lenstec is an ISO 13485 Registered company manufacturing CE Marked products.