Alcon receives FDA Approval for pre-loaded intraocular lens delivery system to treat patients undergoing cataract surgery

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The FINANCIAL — Alcon, one of the global leaders in eye care and a division of Novartis, has received US Food and Drug Administration (FDA) approval for its AcrySof IQ Aspheric IOL with the UltraSertTM Pre-loaded Delivery System for patients undergoing cataract surgery.

This new delivery system combines the control of a manually loaded device with the safety and convenience of a disposable, pre-loaded injector to optimize the implantation of the AcrySof IQ Aspheric IOL into the cataract patient’s eye. Nearly four million cataract surgeries are performed each year in the US. The UltraSertTM Pre-loaded Delivery System received the European CE mark in June 2015, according to Novartis.

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

In cataract surgery, controlling the speed of delivery of the IOL when inserted into the eye is an important factor in achieving a successful cataract procedure.  Alcon has addressed this critical factor in the UltraSert Pre-loaded Delivery System with the TensionGlideTM Plunger, a spring-controlled mechanism designed for a smooth, controlled delivery of the AcrySof IQ IOL into the capsular bag. In addition, the UltraSert Pre-loaded Delivery System features a plunger tip which is designed to support consistent IOL folding and precise placement into the capsular bag of the eye.

The design of the new UltraSert Pre-loaded Delivery System also helps to create a less invasive corneal incision during cataract surgery. The smaller nozzle tip allows for a corneal incision down to 2.2 mm[4] for insertion of the IOL while the Depth GuardTM nozzle of the delivery system prevents the device from being inserted deeper into the incision than necessary, preserving the size of the original corneal incision.

“In testing this device, I was immediately impressed with its smooth control and single hand delivery,” said Dr. Robert Lehmann, M.D., F.A.C.S, a practicing ophthalmologist at the Lehmann Eye Center of Nacogdoches, Texas, USA. “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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