CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
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 You Should Do
Remedy
The firm initiated their market withdrawal by letter on 08/28/2018. The firm requested surgeons immediately cease implantation of the device and return any unused product.
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Products
CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
- Brand
- Alcon Research, LTD.
- UPC
- GTIN: 00380657540037 All lot/serial numbers
Units Affected
30561 units