Z-2679-2024 Class II Ongoing

Recalled by Alcon Research LLC — Fort Worth, TX

Recall Details

Product Type
Devices
Report Date
August 28, 2024
Initiation Date
July 15, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,481 units

Product Description

Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A 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: 8065752451; UDI-DI: 380657524518; Lot numbers: 16AUN4, 16AUN3, 16C9PX, 16C9PY, 16C9R0.