Z-0187-2019 Class I Terminated
FDA device recall Z-0187-2019 was initiated by Alcon Research, LTD. on August 28, 2018 and is designated Class I. Reason for recall: 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 w… The recall status is terminated (terminated December 18, 2020). Affected quantity: 38682 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 31, 2018
- Initiation Date
- August 28, 2018
- Termination Date
- December 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38682 units
Product Description
CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
Reason for Recall
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.
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.
Code Information
GTIN: 00380657540075, 10380657540072, 20380657540079 All lot/serial numbers