CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
Reported: October 31, 2018 Initiated: August 28, 2018 #Z-0186-2019
Product Description
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
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.
Details
- Recalling Firm
- Alcon Research, LTD.
- Units Affected
- 14264 units
- 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.
- Location
- Sinking Spring, PA
Frequently Asked Questions
What product was recalled? ▼
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.. Recalled by Alcon Research, LTD.. Units affected: 14264 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 31, 2018. Severity: Critical. Recall number: Z-0186-2019.
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