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FDA clears femtosecond laser for arcuate incisions in cataract surgery

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ABBOTT PARK, Ill. — The U.S. Food and Drug Administration has cleared the iFS advanced femtosecond laser to create bow-shaped or curved arcuate incisions in corneal surgery, including cataract surgery, Abbott Medical Optics announced in a news release.

“This is a major advancement and expansion of our femtosecond laser technology,” Jim Mazzo, senior vice president of AMO, said in the release. “This is an important step as we look to utilize femtosecond laser technology as a potential standard of care during the cataract procedure.”

The laser is already approved to create LASIK flaps and other corneal incisions, the release said. The FDA clearance will now allow surgeons to make bladeless arcuate incisions during surgery with more precision and predictability than is possible manually and to customize the incision as needed for individual patients.

“We have adapted our current software to be able to produce very precise, reproducible arcuate incisions,” Leonard Borrman, PharmD, divisional vice president of research and development for Abbott Medical Optics, said during a panel discussion at the Ophthalmology Innovation Summit in Chicago.

The company earned CE mark approval for arcuate incisions late last year and with the 510(k) clearance from the U.S. Food and Drug Administration would be launching use of the laser for arcuate incisions within the United States during OIS and ASCRS in Chicago this weekend, Borrmann said.