Alcon recalls CyPass Micro-Stent systems due to statistically significant endothelial cell loss in long-term studies. Affected products include specific catalog numbers and lot/serial numbers. Consumers should contact Alcon for details.
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 its CyPass Micro-Stent systems because long-term studies showed these devices caused significantly more endothelial cell loss compared to standard cataract surgery. This could lead to vision issues if the stent is used without proper medical oversight.
The recall is based on long-term study data showing that the CyPass Micro-Stent group had significantly higher endothelial cell loss compared to those who had traditional cataract surgery. This loss of eye tissue could affect vision over time.
People who have received the CyPass Micro-Stent system for eye surgery are likely affected. Patients who had the procedure under medical supervision are at the highest risk.
Check for the CyPass Ultra System, CyPass Micro-Stent, or CyPass Applier with catalog numbers 8065754007 and related lot/serial numbers. The product is intended for ophthalmic use only.
Reach out to Alcon directly for specific details about your product and next steps.
The recall is based on long-term study data showing higher endothelial cell loss compared to traditional cataract surgery, but it does not indicate immediate danger to users.
Check for the CyPass Ultra System, CyPass Micro-Stent, or CyPass Applier with catalog numbers 8065754007 and related lot/serial numbers.
Contact Alcon directly for specific details about your product and next steps.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-0187-2019 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-0187-2019 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.
