Ophthalmic surgical knives recalled for blade sharpness defect
Alcon Research LLC is recalling 7,108 ClearCut and A-OK ophthalmic surgical knives due to increased complaint reports about blade sharpness. The affected knives 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: FDA Class II classification with no reported illnesses or injuries. However, the product is a surgical instrument used in delicate eye surgery, and a sharpness defect could compromise surgical precision and patient safety. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alcon Research LLC is recalling ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance ophthalmic surgical knives due to an increase in complaint reports related to blade sharpness. The recall affects 7,108 units distributed nationwide and to countries including Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, and many others.
Affected lot numbers are 16AUM5, 16C9RE, 16DDFN, 16HE6A, 16HYDP, 16HYDR, and 16HYDT. The Model/Catalog Number is 8065752437.
Consumers and healthcare providers using these surgical knives should contact Alcon Research LLC with questions or to report any issues related to blade sharpness.
The recalled product
- Product
- Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A
- Manufacturer
- Alcon Research LLC
- Affected units
- 7,108
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 (9)
- Model/Catalog Number: 8065752437
- UDI-DI: 380657524372
- Lot numbers: 16AUM5
- 16C9RE
- 16DDFN
- 16HE6A
- 16HYDP
- 16HYDR
- 16HYDT.
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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