Femtosecond laser cleared for lens fragmentation

May 7, 2010

The FDA has granted 510(k) clearance to a femtosecond laser (LenSx, LenSx Lasers Inc.) for use in cataract surgery. Specifically, the device is used for laser phacofragmentation.

Aliso Viejo, CA

-The FDA has granted 510(k) clearance to a femtosecond laser (LenSx, LenSx Lasers Inc.) for use in cataract surgery. Specifically, the device is used for laser phacofragmentation.

“The . . . phacofragmentation clearance is an important milestone in delivering the benefits of laser refractive cataract surgery to patients, including the reduced use of ultrasonic power to fragment and remove the cataractous lens,” said Stephen G. Slade, MD, of Houston, who performed the initial series of procedures with the laser in the United States.

Laser phacofragmentation with this laser resulted in a 43% reduction in average phaco power and a 51% reduction in effective phaco time, according to a study published in the

Journal of Refractive Surgery.

Additional reported benefits of the technology included the ability to deliver a perfectly centered and sized capsulotomy, resulting in more reproducible positioning of the replacement IOL and in the potential for reduced dependence on eyeglasses, said LenSx in a prepared statement.