Alcon recalls CyPass Micro-Stent implants due to higher risk of 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 implants after studies showed these implants caused significantly more endothelial cell loss compared to standard cataract surgery. This could lead to vision problems if not addressed by an eye specialist.
Long-term studies found that patients with the CyPass Micro-Stent had significantly more loss of endothelial cells in the eye compared to those who had standard cataract surgery. Endothelial cells help maintain proper eye function, so this loss could affect vision over time.
Patients who received the CyPass Micro-Stent implant for eye pressure management. Those with existing eye conditions may be at higher risk of vision issues.
The CyPass Micro-Stent implant is used for eye pressure management. Check if you have the product with lot/serial numbers listed in the recall notice or the GTIN 00380657540105.
Contact your eye doctor to discuss whether the CyPass Micro-Stent implant may need evaluation due to potential endothelial cell loss.
The recall is based on studies showing higher endothelial cell loss with the CyPass Micro-Stent compared to standard cataract surgery, but it does not indicate immediate danger to most users.
No immediate action is required to stop using the implant, but consulting an eye doctor is recommended to evaluate potential risks.
Check if you have the CyPass Micro-Stent implant with lot/serial numbers listed in the recall notice or the GTIN 00380657540105.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-0188-2019 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-0188-2019 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.
