# FDA recall Z-1328-2021

> **Alcon Research, LLC** · Class II · device recall initiated 2021-02-02.

## Product

Alcon Custom Ophthalmic Surgical Procedure Packs

## Reason for recall

Reports have been received concerning mold found on gowns  included in custom ophthalmic surgery packages.

## Distribution

Distribution US nationwide, including Puerto Rico;  Canada, Australia, New Zealand, Mexico, Malaysia, and Thailand

## Key facts

- **Recall number:** Z-1328-2021
- **Recalling firm:** Alcon Research, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-02
- **Report date:** 2021-04-07
- **Termination date:** 2023-06-30

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1328-2021

## Citation

> AI Analytics. FDA recall Z-1328-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1328-2021. Source: US FDA. Licensed CC0.

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