Alcon ophthalmic surgical knives recalled for sharpness and performance degradation
Alcon is recalling surgical instrument packs that include ClearCut and A-OK brand ophthalmic knives due to increasing complaints about sharpness loss. The affected knives could impact surgical precision during 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: This is an FDA Class II recall of surgical instruments used in eye procedures. While no injuries or illnesses have been reported, surgical knives experiencing sharpness loss represent a risk of harm to surgical precision and patient outcomes. The recall is based on increasing complaint reports about actual performance issues.
Plain-English summary
Alcon Research LLC is recalling the 25+ TTL PLUS VPAK 20000CPM BWV, a surgical instrument assembly used with the Constellation Vision System. The recall involves specific ophthalmic knife models: ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance knives. Approximately 8,701 units have been distributed.
Alcon has detected an increase in complaint reports regarding sharpness loss in the affected knives. Loss of sharpness in surgical instruments can compromise the precision required for eye procedures and surgical outcomes.
The affected units were distributed nationwide in the United States and internationally across more than 50 countries, including Canada, Europe, Asia, Australia, and Latin America. The following lot numbers are affected: 16A6HT, 16A6HU, 16A6HV, 16FX1Y, 16FX20, 16FE93, 16HE6Y, 16HE70, 16HYEN, and 16HYEP.
The recalled product
- Product
- Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Description: Standardized assemblage of components, which includes the valved trocar entry system, that interface with the CONSTELLATION Vision System. Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- sharpness-loss
- surgical-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 (12)
- Model/Catalog Number: 8065830077
- UDI-DI: 380658300777
- Lot numbers: 16A6HT
- 16A6HU
- 16A6HV
- 16FX1Y
- 16FX20
- 16FE93
- 16HE6Y
- 16HE70
- 16HYEN
- 16HYEP.
Distribution
Distributed nationwide across the United States.
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