Recall Z-0185-2019
Alcon Research, LTD. · initiated August 28, 2018
Class I – dangerous or defective products that could cause serious health problems or death
Product
CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
Codes / lots: GTIN: 00380657540037 All lot/serial numbers
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.
FDA-determined 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.
Details
- Recall number
- Z-0185-2019
- Initiated
- August 28, 2018
- Posted by FDA
- October 23, 2018
- Terminated
- December 18, 2020
- Product code
- OGO – Intraocular Pressure Lowering Implant
- 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 Uruguay.
- Recalling firm
- Alcon Research, LTD., Sinking Spring, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0186-2019 Class I | CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS…Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent… | 08/28/2018Terminated |
| Z-0187-2019 Class I | CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For…Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent… | 08/28/2018Terminated |
| Z-0188-2019 Class I | CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS…Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent… | 08/28/2018Terminated |