Alcon ophthalmic surgical knives recalled for sharpness defects
Alcon is recalling ophthalmic surgical knives (model 8065990002) due to increased complaint reports regarding sharpness. Approximately 9,384 units have been distributed domestically 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 is a Class II recall of a surgical instrument with a defect that could affect surgical precision in ophthalmic procedures. Although no injuries are reported in the source material, the sharpness defect represents a risk-of-harm situation in precision eye surgery, meeting the threshold for High severity per the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alcon Research LLC is recalling specific models of ophthalmic surgical knives used in eye surgery procedures. The recalled product is the A-OK SATINCRESCENT FULL HANDLE 2.3MM ANG knife (model 8065990002). The company detected an increase in complaint reports related to sharpness for specific knives in this product line.
Approximately 9,384 units have been distributed nationwide in the United States and to healthcare facilities in 41 countries worldwide. The affected lot numbers are 169L2V and 16H1KP.
Ophthalmic surgical knives are precision instruments used in eye surgery. A defect in sharpness could affect surgical precision and performance. Healthcare providers and surgical facilities using the affected lot numbers should review their inventory and consider discontinuing use of the recalled instruments.
Healthcare professionals and institutions that have used these products should consult with Alcon regarding the recall. The FDA is monitoring this Class II recall to ensure appropriate corrective actions.
The recalled product
- Product
- Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Affected units
- 9,384
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: 8065990002
- UDI-DI: 00380659900020
- Lot numbers: 169L2V
- 16H1KP.
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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