Alcon Recalls CyPass Micro-Stent Implant Due to Endothelial Cell Loss
Alcon is recalling the CyPass Micro-Stent implant because long-term study data showed statistically significant endothelial cell loss in patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (endothelial cell loss) where specific injury counts are not reported in the source text, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Alcon Research, LTD. is recalling the CyPass System 241, Intraocular Pressure Lowering Implant, specifically the CYPASS MICRO-STENT and CYPASS APPLIER (REF: 8065754001). This medical device is intended for ophthalmic use. The recall affects 14,264 units distributed worldwide, including the United States, Puerto Rico, and numerous international locations such as Argentina, Australia, Canada, and the United Kingdom.
The recall was initiated following an analysis of the completed dataset from the COMPASS-XT long-term study. The data indicated that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to a group that underwent cataract surgery alone. Endothelial cell loss is a condition affecting the cornea that can impact vision.
Patients who have had this implant placed should contact their eye care provider to discuss the findings and determine appropriate next steps. The recall covers all lot and serial numbers for the specified reference number.
The recalled product
- Product
- CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
- Manufacturer
- Alcon Research, LTD.
- Hazard
- Affected units
- 14,264
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- GTIN: 00380657540013
- 0080657540013
- 20380657540017
- 10380657540010
- 00380657540013 All lot/serial numbers
Distribution
Part of a larger recall action
This product is one of 4 recalled by Alcon Research, LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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