Alcon recalled the CyPass Micro-Stent after a long-term study found that it may cause eye damage, vision loss, or blindness when surgeons implant it during glaucoma surgery.
Alcon CyPass Micro-Stent Recall
August 29, 2018 — The FDA announced a recall for Alcon’s CyPass Micro-Stent after determining that safety data from a 5-year follow-up study showed that the device posed an unreasonable risk of causing eye damage.
Side Effects of CyPass Micro-Stent
People with the CyPass Micro-Stent are at risk of losing epithelial cells in the protective outer layer of the eye (cornea). Endothelial cells are important for clear vision. They do not regrow after they are damaged.
What is the Risk?
Some potential side effects of the CyPass Micro-Stent include:
- Eye damage
- Vision loss
- Epithelial cell loss
- Eye pain
- Need for a corneal transplant
- Glaucoma progression
What is the CyPass Micro-Stent?
The CyPass Micro-Stent is a device that is implanted in a person’s eye during glaucoma surgery. It is used to reduce pressure in the eye, which helps prevent the progression of glaucoma.
What is the Problem?
Alcon recalled the CyPass Micro-Stent worldwide after the 5-year data from the COMPASS-XT study indicated that the stent could damage endothelial cells in the eye. The stent was originally approved in July 2016 based on positive results from a 2-year COMPASS-XT study.
Eye Damage from Compass Micro-Stent
Five years after glaucoma surgery, researchers found significant endothelial cell loss among patients who received the CyPass Micro-Stent compared to cataract surgery patients. They were concerned that endothelial cell loss could lead to eye damage or vision loss.