CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
Check against the official notice below — it lists the full affected range.
Alcon Research, LTD. is recalling the CyPass System 241-S, which includes the CyPass Micro-Stent, CyPass Loaded, and CyPass Applier devices used in eye surgery. The recall was initiated after analysis of data from the COMPASS-XT long-term study showed that patients who received the CyPass Micro-Stent experienced statistically significant endothelial cell loss (a decrease in cells lining the inner surface of the cornea) compared to patients who had cataract surgery alone. Approximately 30,561 units of this device have been distributed worldwide.
The affected devices were distributed across the United States, including Puerto Rico, and internationally to 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. All lot and serial numbers of the CyPass System are included in this recall. The source does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 30561 units Lot/code info: GTIN: 00380657540037 All lot/serial numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.