Z-2654-2024 Class II Ongoing
FDA device recall Z-2654-2024 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: 18,726 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 28, 2024
- Initiation Date
- Jul 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,726 units
Product Description
Reason for Recall
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2654-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026