When did the AcrySof® ReSTOR® Lens and the ReZOOM Lens receive FDA approval?
The US FDA approval was granted to Alcon Laboratories, Inc, on March 23, 2005, for use of the new ReSTOR® Lens in the United States; FDA approval was granted to Advanced Medical Optics (AMO) for the new ReZOOM Lens later the same year. However, significant experience with and information about the implants in Europe and South America were already available where over 12,000 multifocal lenses have been implanted since April 4, 2003, and with similar results as achieved in the US FDA studies.
