FDAFDA · Food and drugs·Recall number Z-0185-2019
CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
Published October 31, 2018 · Recall initiated: August 28, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alcon Research, LTD.
- Distributor
- Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, France, Finland, Germany, Hong Kong, Iceland, Italy, Mexico, Peru, Singapore, Spain, Sweden, Switzerland, United Kingdom, and Uruguay.
- Lot
- GTIN: 00380657540037 All lot/serial numbers
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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