If your physician used a CyPass Micro-Stent during your glaucoma surgery, you might be entitled to substantial compensation from the manufacturer of the medical device if you have sustained injuries or complications caused by the eye stent. Your first priority is to seek medical attention. Report any side effects, symptoms, or complications to your eye doctor immediately.
To discuss filing a claim against Alcon Research LTD, contact our CyPass Micro-Stent lawsuit attorneys to discuss your situation. Our lawyers have extensively researched this medical device to determine the potential defects and causes of action under product liability laws. Do not wait. Your time to file a claim is limited by law. It is best to find out about your rights and options now from an experienced product liability lawyer.
What is the CyPass Micro-Stent?
Alcon Research LTD is the manufacturer of the CyPass Micro-Stent. The FDA approved the use of the eye stent in 2016 based on research by Alcon. The eye stent was used by physicians during glaucoma surgery to reduce the pressure in the eye. The stent was implanted the eye during surgery to help reduce further vision loss and the progression of glaucoma. However, many patients began experiencing serious complications and side effects from the use of the eye stent.
How Was the CyPass Eye Stent Recalled?
During a two year study of patients who had the CyPass Micro-Stent, Alcon did not find a substantial loss of corneal cells in patients with the eye stent versus patients without the eye stent. However, the FDA required Alcon to continue to follow patients for five years after surgery. Results from the extended study revealed a significant increase in the risk of eye injury to a patient who had the CyPass Micro-Stent implanted during surgery.
Therefore, the FDA issued a Class 1 Recall, the most serious of FDA recalls, on August 28, 2018. The FDA warned doctors and patients of the risk of serious side effects and injuries in a Safety Communication on September 14, 2018.
An Update to the Safety Communication was issued on October 24, 2018, by the FDA. The FDA recommended that doctors cease implanting CyPass Micro-Stents and return all unused devices to Alcon. Patients should be evaluated periodically for loss of endothelial cells and the positioning of the CyPass Micro-Stent. Based on the evaluation, a surgeon would need to determine if surgical interventions were needed.
Patients and physicians are encouraged by the FDA to report an adverse event to the FDA immediately through its adverse reporting system.
Potential Side Effects and Adverse Conditions Associated with the CyPass Micro-Stent
The potential complications and side effects reported by patients with the CyPass Micro-Stent include:
- Vision loss
- Eye pain
- Cornea damage
- Glaucoma progression
- General eye damage
- Eye swelling
- Corneal transplants
- Cloudy vision
- Surgery to remove the CyPass Micro-Stent
Contact a CyPass Micro-Stent Lawsuit Attorney for More Information
Individuals who have the Alcon CyPass Micro-Stent implanted in their eye who have suffered complications, injuries, or side effects should contact a defective medical device attorney immediately to discuss their case.
For a confidential, no-obligation care review contact Attorney Fred Olinde of The Olinde Firm. Call (504) 587-1440 or 1-800-587-1889 now to schedule your free consultation with a New Orleans defective medical device attorney.