Ophthalmic surgical knives recalled for increased reports of dulled blades
Alcon recalls specific ClearCut and A-OK ophthalmic surgical knives after reports of reduced blade sharpness. About 7,598 units were distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with reported complaints of reduced blade sharpness in a precision surgical instrument used in eye surgery. While no injuries have been reported in the source text, this falls under risk-of-harm products where injury has not yet been reported. The increase in complaints indicates an actual field problem.
Plain-English summary
Alcon Research LLC is recalling specific ClearCut Dual Bevel Sideport and A-OK ophthalmic surgical knives (Model 8065983265, Lot numbers 16JV6H and 16DFL3) after detecting an increase in complaint reports related to blade sharpness. Approximately 7,598 units are affected.
These precision surgical instruments are used in eye surgery. The affected units were distributed domestically throughout the United States and internationally to over 40 countries.
Healthcare providers and facilities with questions or concerns about these products should contact Alcon Research LLC or the FDA.
The recalled product
- Product
- Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number: 8065983265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Affected units
- 7,598
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model/Catalog Number: 8065983265
- UDI-DI: 00380659832659
- Lot numbers: 16JV6H
- 16DFL3.
Distribution
Part of a larger recall action
This product is one of 36 recalled by Alcon Research LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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