Staar Surgical Implantable Vision Correction Lens OK’d

FDA has approved a Staar Surgical PMA for the EVO/EVO+ Visian Implantable Collamer Lens (ICL) for correcting myopia and myopia with astigmatism. “The EVO lens is additive, provides excellent quality of vision day and night, does not cause dry eye syndrome and is removable by a doctor,” the company says. EVOs are implanted within the eye’s posterior chamber and directly behind the iris and in front of the natural crystalline lens, it says. Earlier versions of the Visian ICL lens in the U.S. required a preoperative peripheral iridotomy that is now eliminated with EVO.

The EVO offers a lens-based alternative for correcting and reducing refractive error in people who currently use glasses or contact lenses for distance vision correction, according to Staar. Approval was based on data from a multicenter, prospective clinical investigation which confirmed the safety of the EVO family of myopia lenses, it says.