Recall Z-2659-2024— Alcon Research LLC

Class II · Ongoing

Class II FDA medical device recall by Alcon Research LLC, initiated 2024-07-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife Component: N/A. Reason: 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
Classification
Class II
Status
Ongoing
Initiated
2024-07-15
Firm location
Fort Worth, TX, United States

Product description

Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.