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.
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 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.
See all 36 products in this recall →Related recalls
Same manufacturer · Alcon Research LLC
See all →- SevereGenTeal Tears Lubricant Eye Gel Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-05-06
- SevereSystane Lubricant Eye Gel Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-05-06
- CriticalOphthalmic surgical packs recalled over incomplete seals affecting sterility
FDA (Devices) · 2025-12-31
- ModerateVitrectomy probe packs recalled with no reason stated in the record
FDA (Devices) · 2025-12-03
- HighInfusion line packs recalled over incomplete seals in sterile pouches
FDA (Devices) · 2025-11-05
Same hazard · blade sharpness
See all →- HighAlcon ophthalmic surgical knives recalled for blade sharpness defects
FDA (Devices) · 2024-08-28
Similar recalls
- HighOphthalmic surgical knives recalled due to sharpness complaints
FDA (Devices) · 2024-06-05
- HighClearCut and A-OK ophthalmic surgical knives recalled for sharpness issues
FDA (Devices) · 2024-06-05
- HighAlcon ClearCut S and A-OK ophthalmic surgical knives recalled for sharpness defects
FDA (Devices) · 2024-06-05
- HighOphthalmic surgical knives recalled for sharpness defects
FDA (Devices) · 2024-06-05
- HighFDA Recalls Sharpoint IQ Slit Knives Due to Potential Bent Tips
FDA (Devices) · 2012-11-14
- ModerateSurgical Specialties Recalls Sharpoint IQ Slit Knives Due to Bent Tips
FDA (Devices) · 2012-11-14