CyPass ULTRA SYSTEM — Class I medical device recall Z-0187-2019
Terminated recall by Alcon Research, LTD., reported 2018-10-31, distributed nationwide. Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group
| Recall number | Z-0187-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, LTD., Sinking Spring, PA, United States |
| Recall initiated | 2018-08-28 |
| Classified | 2018-10-23 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2020-12-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, CA, CH, CL, CO, CR, DE, DK, DO, EC, ES, FI, FR, GB, HK, IS, IT, MX, PE, SE, SG, UY |
| Quantity | 38,682 units |
| UPC / GTIN / UDI-DI | 00380657540075, 10380657540072, 20380657540079 |
| Model numbers | 8065754007 |
Product
CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0187-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.