Recall Z-0187-2019 ยท OGO Intraocular Pressure Lowering Implant
Alcon Research, LTD.
CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
| Date | Oct 23, 2018 (initiated Aug 28, 2018) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 38682 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 Kong, Iceland, Italy, Mexico, Peru, Singapore, Spain, Sweden, Switzerland, United Kingdom, and Urugua |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.