# FDA recall Z-0099-2024

> **Alcon Research, LLC** · Class II · device recall initiated 2023-08-18.

## Product

Constellation Vision System, REF: 8065751150

## Reason for recall

Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.

## Distribution

US: GA, IL, PR

## Key facts

- **Recall number:** Z-0099-2024
- **Recalling firm:** Alcon Research, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-18
- **Report date:** 2023-10-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0099-2024

## Citation

> AI Analytics. FDA recall Z-0099-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0099-2024. Source: US FDA. Licensed CC0.

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