CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophth
FDA device recall Z-0188-2019 · posted 2018-10-23 · Terminated
Recall details
- Recalling firm
- Alcon Research, LTD.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OGO
- Quantity affected
- 480 units
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, France, Finland, Germany, Hong Ko
- Date initiated
- 2018-08-28
- Date posted
- 2018-10-23
- Date terminated
- 2020-12-18
- Location
- Sinking Spring, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.