Alcon Recalls CyPass Micro-Stent Due to Endothelial Cell Loss
Alcon Research is recalling CyPass Micro-Stent devices because long-term study data showed statistically significant endothelial cell loss in patients.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Alcon Research, LTD. is recalling the CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, and CYPASS APPLIER (Catalog # 8065754003) for ophthalmic use. The recall affects 30,561 units distributed worldwide, including the United States, Puerto Rico, and numerous international markets.
The recall was initiated after analysis of the completed dataset from the COMPASS-XT long-term study indicated that patients in the CyPass Micro-Stent group experienced statistically significant endothelial cell loss compared to those who underwent cataract surgery alone.
Consumers and healthcare providers should contact Alcon Research for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
- Manufacturer
- Alcon Research, LTD.
- Category
- Medical Device — Ophthalmic
- Hazard
- Affected units
- 30,561
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 (1)
- GTIN: 00380657540037 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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