OPHTHALMOLOGY/LASER SURGERY: Applause, warning, and approvals make news in laser ophthalmic surgery

IBM scientists who developed excimer lasers for medical application—which launched Laser-Assisted In Situ Keratomileusis (LASIK) surgery among other applications—will receive the U.S. National Medal of Technology and Innovation in 2013. But the U.S. Food and Drug Administration (FDA) has warned five eyecare providers to stop misleading advertising/promo of refractive lasers used in procedures such as LASIK that provided inadequate information about risks. Although LASIK is gloriously effective for the vast majority of patients, significant controversy has been ongoing for years regarding a small number of people whose eyesight was ruined by the irreversible treatment.

Meanwhile, Iridex (Mountain View, CA) has received both FDA 510(k) and CE clearance of its new laser system for treatment of retinal diseases. And LensAR's (Orlando, FL) laser system for refractive cataract surgery received FDA 510(k) clearance for executing corneal incisions—meaning that the system has now been approved for all the critical components of laser cataract surgery including lens fragmentation, anterior capsulotomy (with or without phacofragmentation), and corneal incisions.

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