The Food and Drug Administration Approves CustomVue Monovision Laser-Assisted In Situ Keratomileusis for Marketing

摘要

As fall approaches, the Food and Drug Administration (FDA) seems to be working overtime. It has engaged in many new initiatives and approved new devices. In a significant move, the FDA approved for marketing the first laser-assisted in situ keratomileusis (LASIK) device designed for treating one eye to see far away objects and the other eye for close-up vision. The agency noted that the approval of the CustomVue Monovision LASIK expands permanent vision correction options for nearsighted adults who also have trouble focusing on objects close-up. Unlike the traditional LASIK, Monovision LASIK may reduce the need for reading glasses in some people older than 40 years. Laser-assisted in situ keratomileusis is a procedure in which the surgeon cuts a flap in the outer layers of the cornea, removes a small amount of the tissue beneath it with laser, and then replaces the flap.