# FDA recall Z-1794-2020

> **Alcon Research LLC** · Class II · device recall initiated 2018-07-25.

## Product

Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile.  The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.

## Reason for recall

There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.

## Distribution

There was no domestic distribution.  Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova.

## Key facts

- **Recall number:** Z-1794-2020
- **Recalling firm:** Alcon Research LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-25
- **Report date:** 2020-04-29
- **Termination date:** 2020-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fort Worth, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1794-2020

## Citation

> AI Analytics. FDA recall Z-1794-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1794-2020. Source: US FDA. Licensed CC0.

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