# FDA recall Z-1269-2022

> **Alcon Laboratories Ireland, Ltd** · Class II · device recall initiated 2022-05-11.

## Product

Alcon Clareon IOL with AutonoMe Delivery System

## Reason for recall

Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.

## Distribution

U.S.: AL, CA, FL, GA, IA, IL, KY, LA, MI, MO, NY, OH,OK, TX, VA, and WI     O.U.S.: Czech Republic, France, Germany, India, Slovakia, Spain, and Switzerland

## Key facts

- **Recall number:** Z-1269-2022
- **Recalling firm:** Alcon Laboratories Ireland, Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-05-11
- **Report date:** 2022-06-29
- **Termination date:** 2025-02-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cork, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1269-2022

## Citation

> AI Analytics. FDA recall Z-1269-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1269-2022. Source: US FDA. Licensed CC0.

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