Alcon Research LLC: Device Recall

Recall #Z-2646-2024 · 07/15/2024

Class II: Risk

Recall Details

Recall Number: Z-2646-2024
Classification: Class II
Product Type: Device
Recalling Firm: Alcon Research LLC
Status: Ongoing
Date Initiated: 07/15/2024
Location: Fort Worth, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,721 units

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.

Product Description

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

Distribution Pattern

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

Other Recalls by Alcon Research LLC

Class I: Dangerous 11/24/2025

Ophthalmic procedure packs may have incomplete seals affecting sterility.
Class II: Risk 09/30/2025

Potential for a weak seal in some units resulting in compromise in sterility.
Class II: Risk 09/15/2025

XXX
Class II: Risk 08/05/2025

Due to incomplete seals in the pouch which provide the sterile barrier.
Class II: Risk 08/05/2025

Due to incomplete seals in the pouch which provide the sterile barrier.

View all recalls by Alcon Research LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.