Cataract Surgery Device Receives FDA Approval

The FDA has approved a single-use lens delivery system for patients undergoing cataract surgery.

The AcrySof IQ Aspheric Intraocular Lens (IOL) with the UltraSert Pre-loaded Delivery System from Novartis’s eye care division is designed to optimize IOL implantation and help create a less invasive corneal incision during cataract surgery.

"We are addressing a distinct need of cataract surgeons for a single-use system that maximizes their control during surgery and helps them streamline procedures to enable improved patient outcomes, "stated Sergio Duplan, Alcon Region President for the United States and Canada.

The delivery system also features a plunger tip designed to support consistent IOL folding and precise placement into the capsular bag of the eye. The Depth Guard nozzle prevents the device from being inserted deeper into the corneal incision than necessary, preserving the size of the original incision.

“There are many surgeons who are highly interested in pre-loaded devices, and UltraSert represents a major step forward in pre-loaded delivery system technology," said practicing ophthalmologist Robert Lehmann, MD, FAACS, in a press release about the product’s approval. “…In testing this device, I was immediately impressed with its smooth control and single hand delivery. I believe it will give the surgeon excellent control during the procedure to ensure a consistent delivery of the IOL into the eye.”

Potential complications associated with the use of the UltraSert Pre-loaded Delivery System during cataract or IOL implant surgery include corneal endothelial damage, endophthalmitis, retinal detachment, and transient or persistent glaucoma.

Nearly 4 million cataract surgeries are performed in the United States each year, Novartis noted.