Alcon recalls CyPass Micro-Stent devices due to statistically significant endothelial cell loss in long-term studies. Affected patients should consult their eye doctor for evaluation.
Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.
Alcon is recalling CyPass Micro-Stent devices after studies showed these implants caused more endothelial cell loss compared to standard cataract surgery. This could affect eye health over time.
Long-term studies found the CyPass Micro-Stent caused more endothelial cell loss than standard cataract surgery. Endothelial cells protect the cornea, so this loss could affect vision over time.
People who have received the CyPass Micro-Stent implant for eye pressure management. Those with existing eye conditions may be at higher risk.
Check for the CyPass Micro-Stent, Applier, or System 241 devices with the reference number 8065754001. All lot/serial numbers are listed in the recall notice.
Talk to your eye doctor about whether the CyPass Micro-Stent is still appropriate for you based on your eye health.
The recall shows a statistically significant increase in endothelial cell loss compared to standard cataract surgery, but it does not indicate immediate harm or injury.
The recall does not require stopping use; it recommends consulting your eye doctor for evaluation.
The reference number is 8065754001, and all lot/serial numbers are listed in the recall notice.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-0186-2019 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-0186-2019 from Alcon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
