DEC 10, 2012
The FDA has granted the LensAR laser system 510(k) clearance for performing corneal incisions during cataract surgery. The system now has FDA clearance for all key aspects of laser cataract surgery, including lens fragmentation and anterior capsulotomy with or without phacofragmentation and corneal incisions.
The company says the LensAR system increases precision during refractive cataract surgery with its proprietary high-resolution 3-D confocal structured illumination, which analyzes the anatomy of the cataractous eye. The laser can fragment high-grade cataracts for easier removal and create an exact capsulotomy incision for IOL placement.
The system is being sold in the United States, Europe and several other countries.