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Alcon Research LLC recalls 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife
Recalled June 5, 2024 · FDA recall Z-1922-2024 · Alcon Research
Hazard
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives. · FDA Class II
Units
29,190 units
Sold at
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Korea, Kuwait, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom. Product distributed as sterile stand-alone knives have been placed on HOLD. Product included within Alcon Custom Pak (surgical procedure pack) are continuing to be distributed as ceasing distribution would cause immediate market shortage and result in canceled surgeries.
Description
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
Product
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Manufacturer(s)
Alcon Research LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →