Alcon Ophthalmic Surgical Knives Recalled for Sharpness Defects
Alcon recalls TOTAL PLUS ophthalmic surgical knives due to sharpness defect complaints. The 3,197 affected units are 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: FDA Class II medical device recall for a surgical instrument with a documented sharpness defect. Per the rubric, this qualifies as a risk-of-harm product where injury has not been explicitly reported in the source, scoring 3 (High).
Plain-English summary
Alcon Research LLC is recalling the TOTAL PLUS 25+ 7.5CPM VALVE ophthalmic surgical knife (Model 8065751617). The recall involves 3,197 units with lot numbers 16D1KA, 16D1KC, and 16HE5E, distributed nationwide in the United States and internationally to more than 40 countries including Canada, Mexico, Brazil, Australia, and Japan.
Alcon detected an increase in complaint reports related to blade sharpness affecting the ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance models of ophthalmic surgical knives. The sharpness defect could impact surgical performance during eye procedures.
This recall affects hospitals, ambulatory surgical centers, and eye care facilities that have received these instruments.
The recalled product
- Product
- Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- Affected units
- 3,197
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 (5)
- Model/Catalog Number: 8065751617
- UDI-DI: 380657516179
- Lot numbers: 16D1KA
- 16D1KC
- 16HE5E.
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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