Risk Management

2018 September Alert: CyPass Advice

September 16, 2018 Alert

Clinical Advice on CyPass Issued

Dear OMIC Policyholder,

We are contacting you with an update to our email of September 21, 2018. Please check https://www.omic.com/alcon-voluntary-withdrawal-of-cypass-glaucoma-device/ for future updates, as well as links to the materials discussed below.

Risk management recommendations
OMIC recommends that you take the following steps to promote patient safety and reduce your liability exposure:

• Notify patients with CyPass of the market withdrawal in a letter sent via regular mail. Our sample letter to patients is available at https://www.omic.com/alcon-voluntary-withdrawal-of-cypass-glaucoma-device/.
• Place a copy of the letter in the patient’s medical record, and send a copy to the referring ophthalmologist or optometrist.
• When you do examine the patient, determine if there are any signs of unexpected endothelial cell loss or other problems.
• Share your findings with the patient, and explain your plan for monitoring the eye.
• Document the findings and discussion.

Clinical guidance and additional information are available from both Alcon and ASCRS.

• The Alcon guidance mentioned in the FDA announcement 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.
• ASCRS released clinical guidance on CyPass. It is available at http://ascrs.org/sites/default/files/Preliminary_ASCRS%20_yPass_Withdrawal_Consensus_Statement.pdf.

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