Alcon ClearCut and A-OK Ophthalmic Knives Recalled for Reduced Sharpness
Alcon is recalling ClearCut Sideport and A-OK Corneal/Scleral V-Lance ophthalmic knives due to reports of reduced blade sharpness. The recall affects 6,020 units distributed in the United States and internationally.
What this means for you
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 no reported injuries or hospitalizations. A surgical blade that loses sharpness is a risk-of-harm product where injury could occur during delicate ophthalmic procedures. Per the rubric, when no illnesses or injuries are reported and the hazard is theoretical, the score is at most 3.
Plain-English summary
Alcon Research LLC is recalling ClearCut Sideport Knife Dual Bevel 1.2mm Angled and A-OK Corneal/Scleral V-Lance ophthalmic knives. These are surgical knives used in eye procedures.
The company detected an increase in complaint reports indicating that the blades are losing sharpness. A loss of sharpness could impair surgical precision and affect the safety and effectiveness of ophthalmic procedures.
Approximately 6,020 units have been distributed domestically throughout the United States and internationally to numerous countries including Canada, Mexico, Argentina, Brazil, Australia, Japan, and countries across Europe and other regions.
Healthcare facilities and providers should stop using the affected knives. Facilities may contact Alcon Research LLC or the FDA to report adverse events or for additional information regarding the recall.
The recalled product
- Product
- Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- sharpness-defect
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 (3)
- Model/Catalog Number: 8065982465
- UDI-DI: 00380659824654
- Lot number: 169L42
Distribution
Distributed nationwide across the United States.
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