A micro-invasive surgical device named CyPass Micro-Stent used for the treatment of glaucoma was globally recalled by Alcon, a subsidiary of Novartis. The stent was supposed to be used in combination with cataract surgery but the company announced an immediate recall.

The global recall was declared after analyzing post cataract surgery data of five years during the COMPASS-XT long-term safety study.

The US-FDA approved the CyPass Micro-Stent in July 2016 based on two years of the previous COMPASS study data, since there was a significant reduction in intraocular pressure post-implantation accompanied with surgery. But when compared with the patients who had undergone only cataract surgery after 5 years, there was no significant difference in endothelial cell loss.

That is when Stephen Lane, the chief medical officer of Alcon said, “We believe that withdrawing the CyPass Micro-Stent from the market is in patients’ best interest and is the right thing to do. Although we are removing the product from the market now out of an abundance of caution, we intend to partner with the FDA and other regulators to explore labeling changes that would support the reintroduction of the CyPass Micro-Stent in the future.”

In the meantime, Alcon will offer guidelines for all ophthalmic surgeons for managing the patients who have undergone stent implantation.