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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Alcon Research, LTD.
See all →- SevereAlcon Constellation Procedure Pak recalled due to plastic debris risk
FDA (Devices) · 2023-08-23
- SeverePhaco Standalone Tips Recalled Due to Plastic Debris Risk
FDA (Devices) · 2023-08-23
- HighCenturion FMS Pak Recalled Due to Patient Injury Risk from Plastic Debris
FDA (Devices) · 2023-08-23
- SevereAlcon Custom Pak Intraocular Lens Packages Recalled for Plastic Debris Risk
FDA (Devices) · 2023-08-23
- SevereLegion FMS Pak Surgical Instruments Recalled for Patient Injury from Plastic Debris
FDA (Devices) · 2023-08-23
Same hazard · endothelial cell loss
See all →- HighAlcon Recalls CyPass Micro-Stent Due to Endothelial Cell Loss
FDA (Devices) · 2018-10-31
- HighAlcon Recalls CyPass Micro-Stent Implant Due to Endothelial Cell Loss
FDA (Devices) · 2018-10-31
- CriticalAlcon Recalls CyPass Micro-Stent Implant Due to Endothelial Cell Loss
FDA (Devices) · 2018-10-31