FDA Warns Consumers About Danger of Severe Eye Damage with Use of CyPass Micro-Stents
The Swiss medical firm Alcon has announced an immediate recall of its CyPass Micro-Stents from the global market after a study linked the device to an increased risk for severe, potentially irreversible eye damage and other serious health complications. According to a report in the Daily Hornet, the recall came after preliminary data from the COMPASS-XT study found an increased risk of endothelial cell loss among patients who were implanted with the device during cataract surgery compared to others who underwent cataract surgery alone.
Irreversible Eye Damage
Patients who received the stents are at risk of losing cells in the protective outer lawyer of the idea or cornea, according to an alert issued by the U.S. Food and Drug Administration (FDA). Endothelial cells essentially line the inner lawyer of the cornea and are crucial for clear vision. Once damaged, these cells don’t regenerate. Endothelial cell loss might lead to severe problems such as swelling, cloudiness, eye pain, reduced vision and the potential need for a corneal transplant.
The problems with the Alcon stent did not manifest at the two-year mark after the patients’ surgery when COMPASS found similar problems in the CyPass and cataract surgery-only groups. Based on these results, the FDA approved the stent for long-term use in patients with mild to moderate primary open-angle glaucoma. However, the recently completed COMPASS-XT study found a rise in endothelial cell loss in the CyPass group.
In a letter to physicians, Alcon’s chief medical officer said the damage is likely because of the stent’s position within the angle. Based on this new information, the company is advising surgeons to stop implanting these devices and return any unused stents to Alcon. If you have received a CyPass Micro-Stent, the FDA recommends that you talk to your ophthalmologist right away so you can examine your potential options.
Dangerous Medical Devices
Manufacturers of medical devices have a legal obligation to properly test any devices they put on the market. When medical devices turn out to be defective or dangerous, the situation can get extremely complicated because the device, if implanted in the patient’s body, can only be removed by surgery. In some cases, a patient may have to go through multiple surgeries to fix the problem.
If you have been injured or harmed by a defective medical device, you may be able to file a product liability lawsuit against the manufacturer seeking compensation for damages such as medical expenses, lost income, cost of hospitalization, additional surgeries, rehabilitation and pain and suffering. An experienced medical device defect lawyer will be able to advice victims and their families regarding their legal rights and options.