FDA approves Lenstec IOL

St. Petersburg, FL

-The FDA has approved a new IOL (Softec HD, Lenstec) for patients with cataracts.

The lens already is in use throughout the European Union, Australia, Canada, China, and other international markets. More than 1 million of the IOLs have been implanted worldwide since 2005, according to its maker, which also maintains that the IOL is manufactured with a tolerance of 0.125 D.

“Lens variability is one of the leading causes of refractive error for patients who undergo cataract surgery,” said Jim Simms, Lenstec vice president.

The company’s technology reduces variability and enables surgeons to target each patient's prescription better, he added.

In addition to reducing variability, the company’s manufacturing process makes it possible to produce the lenses in 0.25-D increments for prescriptions from +18 to +25 D, according to the company.