Alcon Research LLC: Device Recall

Recall #Z-1922-2024 · 04/22/2024

Class II: Risk

Recall Details

Recall Number
Z-1922-2024
Classification
Class II
Product Type
Device
Recalling Firm
Alcon Research LLC
Status
Ongoing
Date Initiated
04/22/2024
Location
Fort Worth, TX, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29,190 units

Reason for Recall

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 Description

20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Distribution Pattern

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.

Other Recalls by Alcon Research LLC

View all recalls by Alcon Research LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.