Alcon, a global leader in eye care and a division of Novartis, has received European CE Mark for its AcrySof IQ Aspheric Intraocular Lens (IOL) with the UltraSert Pre-loaded Delivery System for patients undergoing cataract surgery.

The new delivery system combines the control of a manually loaded device with the safety and convenience of a disposable, pre-loaded injector to optimize implantation of the AcrySof IQ Aspheric IOL. This approval follows the recent CE Mark for Alcon's trifocal presbyopia-correcting AcrySof IOL which was received in mid-June. More than three million cataract surgeries are performed each year in Europe.

"Alcon is committed to advancing cataract surgery through the continuous development of new technologies and processes," said Franck Leveiller, PhD., Alcon surgical head of research & development. "Every detail of the UltraSert Pre-loaded Delivery System has been engineered with the needs of surgeons, technicians and the outcomes for their patients in mind. By simplifying the device preparation and maximising surgeon control in a single-use system, we have cleared the path for more streamlined procedures and potentially improved patient outcomes."

In cataract surgery, controlling the rate of delivery of the IOL when inserted into the eye is an important factor in achieving a successful cataract procedure. Alcon has addressed this factor in the UltraSert Pre-loaded Delivery System with the TensionGlide 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 of the IOL 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 for insertion of the IOL while the Depth Guard nozzle feature of the delivery system prevents the device from being inserted deeper into the incision than necessary, preserving the size of the original corneal incision.

"It is truly a step forward in pre-loaded delivery system technology," said Khiun Tjia, MD, senior ophthalmologist, Isala Clinics, Zwolle, Netherlands. "Featuring an impressive array of innovations, the UltraSert System acts as an extension of the surgeon during the critical moment of implantation. It helps to maintain the integrity of the incision while facilitating smooth, consistent delivery of the proven AcrySof IQ Aspheric IOL."

A cataract is a clouding of the natural lens of the eye that affects vision. As a cataract develops, the eye's lens gradually becomes harder and cloudy which scatters light rays and allows less light to pass through it, thus reducing the patient's ability to see. The vast majority of cataracts occur as part of normal aging but radiation exposure, taking steroids, diabetes, and eye trauma can accelerate the development of cataracts. Additionally, cataracts can be hereditary and congenital and can present shortly after birth. Cataracts are the most common age-related eye condition and the leading cause of preventable blindness in adults 55 and older. Cataracts are treated by surgically removing the eye's cloudy natural lens and replacing it with an intraocular lens (IOL). More than 98 per cent of cataract surgeries are considered successful and patients can usually return to their normal routines within 24 hours.

As with any surgical procedure, there is risk involved. Potential complications accompanying cataract or implant surgery may include corneal endothelial damage, endophthalmitis, retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon, and transient or persistent glaucoma. Only Alcon qualified viscoelastic(s) should be used with the UltraSert Pre-loaded Delivery System. The use of an unqualified viscoelastic may cause damage to the lens and potential complications during the implantation process.