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LenSx femtosecond laser receives clearance for anterior capsulotomy during cataract surgery

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ALISO VIEJO, Calif. — LenSx Lasers has received 510(k) clearance from the U.S. Food and Drug Administration for its LenSx femtosecond laser, the company announced in a press release. The approval marks the first time a femtosecond platform has been cleared by the FDA for performing anterior capsulotomy during cataract surgery.

Preliminary clinical evaluation demonstrated the ability of the laser platform 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.

"A proper size and shape to the capsulorrhexis is critical to IOL centration and the proper performance of an accommodating IOL," OSN Chief Medical Editor Richard L. Lindstrom, MD, said in the release. "The accuracy and reproducibility of the LenSx femtosecond laser in achieving the ideal capsulorrhexis cannot be duplicated with our current handheld instruments."