Visian ICL implanted; U.S. shipments begin

Monrovia, CA-STAAR Surgical Co. expects to begin U.S. shipments this month of the Visian implantable collamer lens (ICL), a foldable, minimally invasive lens approved for the correction of adult myopia.

John Vukich, MD, surgeon and medical director at the Davis Suehr Dean Medical Center, Madison, WI, was the first to implant the lens in a patient Jan. 10 since the FDA gave its approval in late December.

In that case, the 36-year-old patient had only been able to count fingers when placed 1 foot in front of her, had –9.5 D of myopia, and was unable to see the largest letter on the standard vision chart. Within an hour of the 6-minute procedure, Dr. Vukich reported that the patient could see better than 20/20, according to a STAAR Surgical news release.

The company received indication in late July (see Ophthalmology Times, Aug. 15, 2005) that the FDA had reviewed and approved its pre-market approval application, subject to inspections of the company's facilities and processes.