glaucoma research foundation logo in black
Filter by Categories
Eye Health
Personal Stories
Facts & Stats
Lifestyle Tips
Eye Exams
Treatments
Q&A
Research Updates
News
Filter by Categories
Eye Health
Personal Stories
Facts & Stats
Lifestyle Tips
Eye Exams
Treatments
Q&A
Research Updates
News

Recall: CyPass Micro-Stent Withdrawn Amid Concerns of Endothelial Cell Loss

August 29, 2018 — Alcon has issued a voluntary global recall of the CyPass microstent, effective immediately.

BACK TO BLOG HOME

image of CyPass microstent on a US dime to show scale
image of CyPass microstent on a US dime to show scale

Recall: CyPass Micro-Stent Withdrawn Amid Concerns of Endothelial Cell Loss

August 29, 2018 — Alcon has issued a voluntary global recall of the CyPass microstent, effective immediately.

The recall announcement came after researchers detected a dramatic 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.

“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.”

 

Source: American Academy of Ophthalmology

image_print
back of mailing envelope. snail mail icon.

Print Subscription

We will mail Gleams anywhere in the United States and Canada, but we do not mail internationally. Please sign up for the email edition if you live outside of the US or Canada.

Name(Required)
Address(Required)
This field is for validation purposes and should be left unchanged.

You can unsubscribe at any time. GRF will not share your personal information with any other organizations. Please see our Privacy Policy for further information.

folded paper airplane. email icon.

E-mail Subscription

Name
This field is for validation purposes and should be left unchanged.

You can unsubscribe at any time. GRF will not share your personal information with any other organizations. Please see our Privacy Policy for further information.