News

FDA recalls CyPass glaucoma device

11/29/18 Updated FDA and OMIC Advice

On October 24, 2018, the FDA issued an update on the CyPass device: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm624283.htm. The device status has been changed from a voluntary market withdrawal initiated by Alcon to an FDA Class 1 recall.

Latest FDA recommendations

• Do not implant CyPass Micro-Stents and return unused devices to Alcon. Call Alcon at 1-800-862-5266 for directions on how to return the devices.
• All patients who have the CyPass device should be evaluated periodically for endothelial cell density using specular microscopy until the rate of loss stabilizes.
• Eye care providers should evaluate all patients with CyPass to assess device positioning by visualization of the number of retention rings visible on the proximal end of the device. Patients with two or more rings visible upon examination should be evaluated for endothelial cell loss as soon as possible.
• Based on the endothelial cell density levels, and other factors such as age and time post-implantation, the surgeon should determine if additional surgical interventions (that is, trimming, repositioning, or removal) are appropriate.

OMIC risk management recommendations

Disclosure

• OMIC advised ophthalmologists to notify their patients when CyPass was voluntarily withdrawn from the market.
• If you have already notified the patient as advised, documented the notification, examined the patient, and developed and communicated a monitoring plan, we do not feel you need to send another letter. Instead, discuss the recall at the next appointment.
• If you have not yet notified your patients, do so now. Here is a Letter to patients about the CyPass recall.

Monitoring

• At the next visit, revisit the monitoring plan, and remind patients of symptoms that should be reported to you.
• Evaluate the endothelial cell count if you have not already done so.
• Document the disclosure, exam, and discussion about the endothelial cell count.

If you do not have a specular microscope

• Identify practices or academic centers where counts are available, and determine the cost of the count.
• If the exam does not indicate any relevant problems, tell the patient that you do not feel a count is needed at this time, and explain your monitoring plan AND
• Give the patient the option of having the count done, and explain the cost.
• Document the disclosure, exam, and discussion about getting an endothelial cell count.

OMIC policyholders may obtain confidential advice by contacting our Risk Management Hotline at 800-562-6642, option 4, or riskmanagement@omic.com. 

Alcon information provided after the market withdrawal

During the September 17, 2018 conference call for physicians who have implanted the device, the physician speakers noted that due to fibrosis around the implant, the risk of complications with removal is high. Clinical guidance is available at  https://www.alcon.com/sites/www.alcon.com/files/CyPass_US_Customer_Letter-8-29_Final.pdf. Results of the Compass XT clinical trial were presented at ESCRS. The presentation can be accessed through the Alcon website at https://www.alcon.com/content/cypass-micro-stent-market-withdrawal.

Initial FDA announcement

The FDA released statement about Alcon’s voluntary withdrawal of CyPass may be viewed at https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm620646.htm. In its release, the FDA provides the following advice:

• Do not implant CyPass Micro-Stents and return unused devices to Alcon. Call Alcon at 1-800-862-5266 for directions on how to return the device.
• Review Alcon’s recommendations for evaluating and managing CyPass Micro-Stents in patients who have already received the device, such as repositioning or trimming.
• At the current time it is not known how endothelial cell density loss might continue to progress more than five years after the original surgery, and what impact surgery to remove the device may have on further endothelial cell density loss.

ASCRS interim guidance provided after the market withdrawal

The ASCRS documents can be accessed at the following link: http://ascrs.org/sites/default/files/Preliminary_ASCRS%20_yPass_Withdrawal_Consensus_Statement.pdf.