LenSx Obtains First Femtosecond Laser Approval for Capsulotomies
September 13, 2009
LenSx Lasers announced that it had received 510(k) clearance from the FDA to perform capsulotomies during cataract surgery, becoming the first femtosecond laser company to obtain such clearance.
According to the company, the laser platform demonstrated the ability to produce capsulotomies with diameters that were significantly more uniform and reproducible than manually created capsulorrhexes. The investigators found that intended diameters were achieved in 100% of laser capsulotomies, while a diameter accuracy of ±0.25 mm was observed in 10% of manual procedures.
Richard L. Lindstrom, MD, a consultant to the company stated, “A proper size and shape to the capsulorrhexis is critical to IOL centration and the proper performance of an accommodating IOL. The accuracy and reproducibility of the LenSx femtosecond laser in achieving the ideal capsulorrhexis cannot be duplicated with our current handheld instruments.”
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