CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. 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 because 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 inner surface of the cornea) compared to patients who underwent cataract surgery alone. A total of 14,264 units were distributed worldwide across numerous countries including the United States, Puerto Rico, and locations throughout Central and South America, Europe, and Asia.
The recall affects all lot and serial numbers of the CyPass Micro-Stent and CyPass Applier (GTIN codes: 00380657540013, 0080657540013, 20380657540017, 10380657540010). The source document does not specify a remedy or instructions 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: 14264 units Lot/code info: GTIN: 00380657540013, 0080657540013, 20380657540017, 10380657540010, 00380657540013 All lot/serial numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.