Alcon recalls ClearCut ophthalmic knives due to sharpness issues
Alcon is recalling approximately 11,916 ClearCut SB Intrepid 2.2 ANG ophthalmic knives due to complaints about blade sharpness. The affected units were distributed nationwide 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 ophthalmic knife is a medical device where blade sharpness degradation presents a risk of surgical complications. No illnesses or injuries are reported in the source material, placing this in the 'risk-of-harm product where injury has not yet been reported' category.
Plain-English summary
Alcon Research LLC is recalling the ClearCut SB Intrepid 2.2 ANG ophthalmic knife (Model/Catalog Number 8065992245), a surgical instrument used in eye surgery. The recall affects approximately 11,916 units with lot numbers 168UH0 and 16H1L6.
Alcon has detected an increase in complaint reports related to sharpness for these ophthalmic knives. The affected units have been distributed nationwide throughout the United States and internationally to numerous countries including Canada, Mexico, Japan, Australia, and various European nations.
This is a Class II recall issued by the FDA.
The recalled product
- Product
- Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Affected units
- 11,916
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: 8065992245
- UDI-DI: 00380659924453
- Lot numbers: 168UH0
- 16H1L6.
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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