# FDA recall Z-0260-2024

> **Alcon Research, LLC** · Class II · device recall initiated 2023-09-07.

## Product

Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR

## Reason for recall

Custom surgical procedure packs contain latex gloves but are labeled as "latex free".

## Distribution

US: VA OUS: None

## Key facts

- **Recall number:** Z-0260-2024
- **Recalling firm:** Alcon Research, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-07
- **Report date:** 2023-11-15

- **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-0260-2024

## Citation

> AI Analytics. FDA recall Z-0260-2024. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-0260-2024. Source: US FDA. Licensed CC0.

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