Alcon’s CyPass Micro-Stent was recalled after a 5-year study of glaucoma patients found a risk of permanent eye damage, vision loss, or blindness.
Alcon CyPass Micro-Stent Recall
In August 2018, the FDA recalled the CyPass Micro-Stent manufactured by Alcon after a safety study showed that it posed an unreasonable risk of causing permanent eye damage.
Side Effects of CyPass Micro-Stent
The study showed that patients with the CyPass Micro-Stent may suffer damage to the epithelial cells in the protective outer layer of the eye (cornea) that is important for keeping clear vision.
What is the Risk?
- Eye damage
- Vision loss
- Epithelial cell loss
- Eye pain
- Need for a corneal transplant
- Glaucoma progression
What is the CyPass Micro-Stent?
Alcon’s CyPass Micro-Stent is implanted in the eye during glaucoma surgery to reduce eye pressure in the eye. This helps prevent progression of glaucoma and other eye complications.
What is the Problem?
Alcon issued a global recall for the CyPass Micro-Stent after the 5-year follow-up data from the COMPASS-XT study found higher rates of eye damage compared to patients who did not receive the stent. The researchers were concerned that excess endothelial cell damage could lead to higher rates of eye damage, vision loss, or other injuries.