Alcon recalls CyPass Micro-Stent devices due to statistically significant endothelial cell loss in long-term studies. Affected units include specific model numbers and lot/serial numbers. No immediate action required per recall 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 CyPass Micro-Stent devices after studies showed these devices caused statistically significant loss of endothelial cells compared to standard cataract surgery. This recall does not require immediate action but addresses a potential risk during eye surgery.
Long-term studies found that patients using the CyPass Micro-Stent experienced a higher rate of endothelial cell loss compared to those who had standard cataract surgery. This loss of cells can impact eye health and vision over time.
Patients who have undergone cataract surgery using the recalled CyPass Micro-Stent devices are affected. Those with the specific model numbers and lot/serial numbers listed in the recall are most at risk.
Check for the CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, or CYPASS APPLIER with the catalog number 8065754003. All lot and serial numbers are included in the recall.
Review the product name and catalog number to confirm if your device is affected.
The recall is based on long-term study results showing higher endothelial cell loss compared to standard surgery, but no immediate harm is reported.
The recall does not require stopping use; the remedy is not specified in the record.
Look for the CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, or CYPASS APPLIER with catalog number 8065754003 and all lot/serial numbers.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-0185-2019 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-0185-2019 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.
