Connect with us

Headlines

Alcon Announces Global Recall of Eye Stent

mm

Published

on

It’s a device used for cataract surgery.

Alcon has announced a voluntary withdrawal of the CyPass Micro-Stent from the global market.

The company is advising surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices. The recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study.

Clinical data “showed it may damage the eye,” Reuters reports.

The U.S. Food and Drug Administration approved the CyPass Micro-Stent in July 2016 for use in conjunction with cataract surgery in adult patients with mild-to-moderate primary open-angle glaucoma. The approval was based on the results of the two-year COMPASS study.

Advertisement

The study demonstrated a statistically significant reduction in intraocular pressure at two years post-surgery in subjects implanted with the CyPass Micro-Stent at the time of cataract surgery, according to a press release from Alcon. That was compared to subjects undergoing cataract surgery alone.

At two years post-surgery, there was little difference in endothelial cell loss between the CyPass Micro-Stent and cataract surgery-only groups, and results were consistent with peer-review literature benchmarks of cataract-related endothelial cell loss, Alcon stated.

The COMPASS-XT study was designed to collect safety data on the subjects who participated in the COMPASS study for an additional three years, with analysis of the completed data set at five years post-surgery. At five years, the CyPass Micro-Stent group experienced statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone, according to Alcon.

SPONSORED VIDEO

With Crizal you can have it all!

Patients expect clarity of vision, scratch resistance, anti-glare technology, easy-to-clean lenses, and UV protection from their lenses. Crizal Sapphire HR is the latest generation of anti-reflective coating that combines our innovative technologies, 360 Multi-angular Technology™, High-Resistance Technology™, High Surface Density Process™ into one coating to deliver best in class performance. Your patients’ main concerns of anti-glare, scratch resistance, and easiness to clean are covered. Crizal Sapphire HR shield the lenses against reflections, scratching, smudging and UV light for long-lasting transparency, durability, and protection. Crizal coatings can be applied to any design, including traditional single vision, Eyezen®, Eyezen+ and Varilux®! Widely available across lab networks and through all major managed vision care providers today. Crizal Saphire HR benefits include: • 360 Multi-angular Technology™ that cuts front and lateral backside reflection • High-Resistance Technology™ that offers the best combination of scratch and smudge resistance • High Surface Density Process™ that ensures the lense is easy-to-clean, smudge resistant and water repellent For more information about Crizal Saphire HR, go here.

Promoted Headlines

Most Popular