Device product
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
Z-0186-2019
Product summary
- Event
- Event 80931
- Status
- Terminated
- Classification
- Class I
- Quantity
- 14264 units
- Official record key
device-enforcement:Z-0186-2019
Official wording
Reason: 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.
Code information: GTIN: 00380657540013, 0080657540013, 20380657540017, 10380657540010, 00380657540013 All lot/serial numbers
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.