# FDA recall Z-2646-2024

> **Alcon Research LLC** · Class II · device recall initiated 2024-07-15.

## Product

Product Name: 25GA VALVED ENTRY SYSTEM,3CT  Model/Catalog Number: 8065751658  Software Version: N/A  Product Description: Valved Trocar Entry System  Component: N/A

## Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

## Distribution

Domestic: Nationwide Distribution  Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

## Key facts

- **Recall number:** Z-2646-2024
- **Recalling firm:** Alcon Research LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-15
- **Report date:** 2024-08-28

- **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-2646-2024

## Citation

> AI Analytics. FDA recall Z-2646-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2646-2024. Source: US FDA. Licensed CC0.

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