Alcon recalls ophthalmic knives due to sharpness defects
Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic knives due to increased complaint reports related to blade sharpness. Healthcare providers should not use affected units pending further evaluation.
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 an FDA Class II recall of surgical instruments where complaint reports related to blade sharpness have been documented. No injuries or illnesses have been reported. As a risk-of-harm product where injury has not yet been reported, it meets the rubric criterion for Score 3.
Plain-English summary
Alcon Research LLC is recalling ophthalmic knives, including ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance models, due to an increase in complaint reports concerning blade sharpness.
The recall affects approximately 53,123 units that were distributed domestically throughout the United States and internationally to over 50 countries. Affected lot numbers include: 1636Y0, 164RX6, 166E81, 166E82, 16ALX5, 16DNMV, 1618V6, 16AM3U, and 16AV0E.
No injuries or illnesses have been reported at this time. Healthcare providers and patients who have received or used affected units should contact Alcon or their healthcare provider for guidance on appropriate next steps.
The recalled product
- Product
- Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 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 (11)
- Model/Catalog Number: 8065992747
- UDI-DI: 00380659927478
- Lot numbers: 1636Y0
- 164RX6
- 166E81
- 166E82
- 16ALX5
- 16DNMV
- 1618V6
- 16AM3U
- 16AV0E.
Distribution
Distributed nationwide across the United States.
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