Z-0188-2019 Class I Terminated
FDA device recall Z-0188-2019 was initiated by Alcon Research, LTD. on Aug 28, 2018 and is designated Class I. 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… The recall status is terminated (terminated Dec 18, 2020). Affected quantity: 480 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 31, 2018
- Initiation Date
- Aug 28, 2018
- Termination Date
- Dec 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 480 units
Product Description
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. 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.
Distribution Pattern
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.
Code Information
GTIN 00380657540105 All lot/serial numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0188-2019
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026