Recall Z-0185-2019 ยท OGO Intraocular Pressure Lowering Implant
Alcon Research, LTD.
CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 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 | 30561 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.