For Cataract Surgeries, FDA Approves Alcon’s Pre-loaded IOL Delivery System

For Cataract Surgeries, FDA Approves Alcon’s Pre-loaded IOL Delivery System

Alcon, a global leader in eye care and a division of Novartis, recently announced that the U.S. Food and Drug Administration (FDA) has given final approval for its AcrySof IQ Aspheric IOL with the UltraSert™ Pre-loaded Delivery System — a novel means of IOL delivery that integrates manual control with the added safety and convenience of a disposable, pre-loaded injector — for patients undergoing cataract surgery. Estimates show that about 4 million people have cataract surgery every year in the United States, presenting a relatively open market for the UltraSert™ system, which received the European CE mark in June 2015.

“The introduction of the UltraSert Pre-loaded Delivery System further reinforces our commitment to advancing cataract surgery through innovation,” said Sergio Duplan, Region President for the United States and Canada, said in a company release. “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.”

Cataract surgery necessitates meticulous control of the speed of IOL delivery. Alcon devised the UltraSert Pre-loaded Delivery System with a TensionGlide™ Plunger, which operates with a spring-controlled mechanism that allows for smooth and controlled delivery of the AcrySof IQ IOL into the patients’ capsular bag. Further, the UltraSert system is built with a plunger tip that can support stable IOL folding and precise placement, and ultimately enables a less invasive corneal incision.

“In testing this device, I was immediately impressed with its smooth control and single hand delivery,” said Dr. Robert Lehmann, MD, FACS, a practicing ophthalmologist at the Lehmann Eye Center of Nacogdoches, Texas. “I believe it will give the surgeon excellent control during the procedure to ensure a consistent delivery of the IOL into the eye. 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.”


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Internationally leading eye care company and subsidiary of Novartis, Alcon, revealed novel surgery innovations during the XXXIII European Society of Cataract and Refractive Surgeons Congress (ESCRS) in Barcelona, Spain, which ran between Sept. 4-9, 2015. Alcon was featured in more than 15 sponsored medical sessions and 24 supported peer-reviewed presentations at the congress.

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