Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software V...
FDA Recall #Z-2671-2024 — Class II — July 15, 2024
Product Description
Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 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.
Recalling Firm
Alcon Research LLC — Fort Worth, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
7,713 units
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
Code Information
Model/Catalog Number: 8065000095; UDI-DI: 380650000958; Lot numbers: 16D1KR, 16D1KU, 16D1KV, 16D1KW, 16D1KX, 16FX1P, 16FX1R, 16HYDY, 16HYE0, 16HYE1.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated