# FDA recall Z-2412-2024

> **Alcon Research LLC** · Class II · device recall initiated 2024-05-23.

## Product

Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

## Reason for recall

After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting in decreased uncorrected visual acuity.

## Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, TN, TX, WA, WI, PR and the countries of Canada, Japan, France.

## Key facts

- **Recall number:** Z-2412-2024
- **Recalling firm:** Alcon Research LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-23
- **Report date:** 2024-07-24

- **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-2412-2024

## Citation

> AI Analytics. FDA recall Z-2412-2024. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/Z-2412-2024. Source: US FDA. Licensed CC0.

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