# FDA recall Z-0835-2025

> **Alcon Research LLC** · Class II · device recall initiated 2024-11-13.

## Product

Brand Name: Alcon  Product Name: Monarch¿ III D Delivery Cartridge  Model/Catalog Number: 8065977763   Product Description: Monarch¿ III D delivery cartridge  Lens Guide, Intraocular  Component: N/A

## Reason for recall

Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery.

## Distribution

US: AK	AL	AR	AZ	CA	CO	CT	DE	FL	GA	GU	HI	IA	ID	IL	IN	KS	KY	LA	MA	MD	ME	MI	MN	MO	MS	MT	NC	ND	NE	NH	NJ	NM	NV	NY	OH	OK	OR	PA	RI	SC	SD	TN	TX	UT	VA	VT	WA	WI	WV	WY  OUS: Russia, Egypt

## Key facts

- **Recall number:** Z-0835-2025
- **Recalling firm:** Alcon Research LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-13
- **Report date:** 2025-01-22

- **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-0835-2025

## Citation

> AI Analytics. FDA recall Z-0835-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0835-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*