CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
Check against the official notice below — it lists the full affected range.
Alcon Research, Ltd. is recalling the CyPass ULTRA SYSTEM, which includes the CyPass Micro-Stent and CyPass Applier, worldwide. 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 reduction in the cells lining the inner surface of the eye) compared to patients who underwent cataract surgery alone. A total of 38,682 units have been distributed across the United States (including Puerto Rico) and numerous other countries including Canada, Australia, the United Kingdom, Mexico, and others.
The source document does not specify a remedy or instructions for consumers who may have received this device.
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: 38682 units Lot/code info: GTIN: 00380657540075, 10380657540072, 20380657540079 All lot/serial numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.