CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
This recall has been terminated (originally issued October 23, 2018).
- Company
- Alcon Research, Ltd.
- Recall Initiated
- August 28, 2018
- Posted
- October 23, 2018
- Terminated
- December 18, 2020
- Recall Number
- Z-0187-2019
- Quantity
- 38682 units
- Firm Location
- Sinking Spring, PA
- Official Source
- View on FDA website ↗
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
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 / Code Info
GTIN: 00380657540075, 10380657540072, 20380657540079 All lot/serial numbers
Root Cause
Device Design
Action Taken
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.