# FDA recall Z-0188-2019

> **Alcon Research, LTD.** · Class I · device recall initiated 2018-08-28.

## Product

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

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.

## Key facts

- **Recall number:** Z-0188-2019
- **Recalling firm:** Alcon Research, LTD.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-28
- **Report date:** 2018-10-31
- **Termination date:** 2020-12-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sinking Spring, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0188-2019

## Citation

> AI Analytics. FDA recall Z-0188-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0188-2019. Source: US FDA. Licensed CC0.

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