Alcon Recalls CyPass Micro-Stent Due to Endothelial Cell Loss
Alcon Research is recalling the CyPass Micro-Stent because long-term study data showed statistically significant endothelial cell loss in patients who received the device.
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 reported adverse health outcome (statistically significant endothelial cell loss) in a long-term study, fitting the 'High' severity criteria for risk-of-harm products where specific injury counts or fatalities are not explicitly reported in the source text.
Plain-English summary
Alcon Research, LTD. is recalling the CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, and CYPASS APPLIER (REF CATALOG #: 8065754007) for ophthalmic use. The recall involves 38,682 units distributed worldwide, including the United States, Puerto Rico, and numerous international markets. All lot and serial numbers are affected.
The recall was initiated after analysis of the completed dataset from the COMPASS-XT long-term study indicated that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.
Patients who have had this device implanted should contact their eye care provider for further evaluation and guidance.
The recalled product
- Product
- CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
- Manufacturer
- Alcon Research, LTD.
- Category
- Medical Device — Ophthalmic
- Hazard
- Affected units
- 38,682
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 (3)
- GTIN: 00380657540075
- 10380657540072
- 20380657540079 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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