Ophthalmic Surgical Knives Recalled for Potential Sharpness Issues
Alcon is recalling specific ophthalmic knives following an increase in complaint reports related to sharpness. These surgical instruments are used in eye procedures.
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: FDA Class II recall of a surgical instrument where reduced sharpness impairs intended function, classified as a risk-of-harm product with no reported patient injuries documented in the source.
Plain-English summary
Alcon Research LLC is recalling specific models of ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance ophthalmic knives due to an increase in complaint reports related to blade sharpness. These surgical instruments are used in ophthalmic procedures.
The recall affects 1,932 units distributed nationwide in the United States and to multiple countries internationally. The affected product model number is 8065772465, with specific lot numbers 15P7RN and 15TFMK.
Ophthalmic surgeons and surgical facilities in possession of affected instruments should contact Alcon Research LLC for instructions regarding replacement or other guidance related to the affected lots.
The recalled product
- Product
- Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number: 8065772465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- reduced-sharpness
- blade-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 (4)
- Model/Catalog Number: 8065772465
- UDI-DI: 00380657724659
- Lot numbers: 15P7RN
- 15TFMK.
Distribution
Distributed nationwide across the United States.
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