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Femtosecond laser approved for fragmentation of lens during cataract surgery
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ALISO VIEJO, Calif. — LenSx Lasers has announced that it has received 510(k) regulatory clearance from the U.S. Food and Drug Administration for use of its femtosecond laser in the phacofragmentation of a cataract.
The indication is the third approval specifically for use during cataract surgery. LenSx received approval for use in creating the anterior capsulotomy in August 2009, as well as an indication for creating a corneal incision with a femtosecond laser in December 2009.
Use of a femtosecond laser to fragment the opacified lens may result in reduction of phaco power, as well as a reduction in overall phaco time, according to a press release announcing the regulatory clearance.
"The LenSx 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," Stephen G. Slade, MD, who performed the first laser-based cataract surgeries in the United States and is an OSN Refractive Surgery Board Member, said in the statement.
Use of laser may also facilitate a more accurate and predictable capsulotomy, which may, in turn, translate to more reproducible positioning of the IOL, the release said.
"Femtosecond laser cataract surgery will enhance refractive outcomes, as well as the safety and operating room efficiency of traditional cataract surgery," Richard L. Lindstrom, MD, OSN Chief Medical Editor, said in the statement.
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