Alcon ClearCut S Ophthalmic Knives Recalled for Sharpness Complaints
Alcon is recalling ClearCut S and A-OK ophthalmic surgical knives due to increased complaint reports about sharpness. Approximately 5,039 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 surgical instrument recall involves a Class II FDA designation with reported complaints about product sharpness that could affect surgical performance. No injuries or illnesses have been reported, but this qualifies as a risk-of-harm product where actual patient harm has not yet been documented.
Plain-English summary
Alcon Research LLC is recalling ClearCut S Safety Sideport Knife (1.2mm Dual Bevel, Model 8065771541) and A-OK Corneal/Scleral V-Lance ophthalmic knives. The recall was initiated due to an increase in complaint reports related to sharpness for these surgical instruments.
The affected products were distributed nationally throughout the United States and internationally to over 40 countries. Approximately 5,039 units are involved in this recall, with the following lot numbers identified: 168NME, 168NND, and 16AV17.
Alcon is providing guidance to healthcare providers and facilities using these instruments. Consumers and medical professionals who have these products should contact Alcon Research LLC for instructions on device replacement or handling of affected inventory.
The recalled product
- Product
- Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- Affected units
- 5,039
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 (5)
- Model/Catalog Number: 8065771541
- UDI-DI: 00380657715411
- Lot numbers: 168NME
- 168NND
- 16AV17.
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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