Cypass recallZ-0187-2019 · Alcon Research, LTD. · initiated Aug 28, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alcon Research, LTD. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Device Design
What the company is doing
The firm initiated their market withdrawal by letter on 08/28/2018. The firm requested surgeons immediately cease implantation of the device and return any unused product.
Recall details
- Recall number
- Z-0187-2019
- Status
- Terminated
- Initiated by the company
- Aug 28, 2018
- Posted by the FDA
- Oct 23, 2018
- Recalling firm
- Alcon Research, LTD.
- Quantity
- 38682 units
- Product code
- OGO
- FDA submissions
- P150037
- 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.
Product description
CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
Code information (models, lots, serial numbers)
GTIN: 00380657540075, 10380657540072, 20380657540079 All lot/serial numbers
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Cypass 8065754007Alcon Laboratories, Inc. · Intraocular pressure lowering implant1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 80931).
- Z-0185-2019 · TerminatedCyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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