LATEST UPDATE: The FDA has issued a Class 1 recall of the CyPass microstent, updating the voluntary market withdrawal initiated by Alcon in August. Class I recalls are issued when a product has a reasonable risk of causing serious health problems. Read the FDA’s recommendations and OMIC’s updated advice on disclosure and monitoring. OMIC provides a sample recall letter and advises ophthalmologists who do not have a specular microscope.
Alcon has announced an immediate, voluntary market withdrawal of the CyPass microstent from the global market.
The announcement came after researchers detected a concerning rise in endothelial cell loss (ECL) among patients who received the CyPass microstent during cataract surgery 5 years ago, compared with patients who underwent cataract surgery alone.
These findings were not evident 2 years after surgery, when the COMPASS safety study found similar ECL in the CyPass and cataract surgery-only groups. Based on those early results, the FDA approved the device for long-term IOP control in patients with mild-to-moderate primary open-angle glaucoma.
But the recently completed COMPASS-XT study, which followed the patients for an additional 3 years, detected a concerning rise in ECL in the CyPass group. In a letter to physicians dated August 29, the company’s chief medical officer, Stephen Lane, MD, said that the damage likely stems from the device’s position within the angle. He noted that the ECL correlated with the number of retention rings noted on clinical examination with gonioscopy, particularly when 2 or more retention rings were visible.
“Based on this new information, we are advising surgeons to immediately cease further implants with the CyPass microstent and to return any unused devices to Alcon,” Lane wrote. Alcon’s Quality team will issue recommendations for evaluating and managing patients who already have the device in place.
The recall is unlikely to have a financial impact on Alcon, a company spokesperson told Reuters. Though economic analysts have estimated the stent’s revenue at around $100 million, the company says CyPass sales were “immaterial” to Alcon’s total sales and will not derail Novartis’ plans to spin off Alcon next year.
“We believe that withdrawing the CyPass microstent from the market is in patients' best interest and is the right thing to do,” Lane says. “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 microstent in the future.”