Home / Recalls / Alcon Research LLC / Z-2647-2024

Z-2647-2024 Class II Ongoing

Recalled by Alcon Research LLC — Fort Worth, TX

FDA device recall Z-2647-2024 was initiated by Alcon Research LLC on Jul 15, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 8,701 units.

Recall Details

Product Type: Devices
Report Date: Aug 28, 2024
Initiation Date: Jul 15, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8,701 units

Product Description

Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Description: Standardized assemblage of components, which includes the valved trocar entry system, that interface with the CONSTELLATION Vision 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 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

Code Information

Model/Catalog Number: 8065830077; UDI-DI: 380658300777; Lot numbers: 16A6HT, 16A6HU, 16A6HV, 16FX1Y, 16FX20, 16FE93, 16HE6Y, 16HE70, 16HYEN, 16HYEP.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2647-2024
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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