CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.
Check against the official notice below — it lists the full affected range.
Alcon Research, Ltd. is recalling the CyPass System 241, an intraocular pressure lowering implant used in eye surgery. The recall was initiated after analysis of data from the COMPASS-XT long-term study found that patients who received the CyPass Micro-Stent experienced statistically significant endothelial cell loss (a reduction in cells lining the cornea) compared to patients who had cataract surgery alone. A total of 480 units with GTIN 00380657540105 across all lot and serial numbers have been distributed worldwide.
The device was distributed to numerous countries including all 50 US states and Puerto Rico, as well as 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. The recall notice does not specify what affected consumers should do regarding this product.
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: 480 units Lot/code info: GTIN 00380657540105 All lot/serial numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.