Alcon A-OK Ophthalmic Knife Recalled for Sharpness Defect
Alcon is recalling A-OK ophthalmic knives due to an increase in reports of sharpness defects. The affected knives are used in eye surgery and may not perform as intended.
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 medical device recall of precision surgical instruments. Although no injuries have been reported, a defect in blade sharpness creates a risk of harm during eye surgery procedures, qualifying this as High severity per the recall rubric.
Plain-English summary
Alcon Research LLC is recalling A-OK 19G V-LANCE ophthalmic knives (Model 8065911901) due to an increase in complaint reports related to sharpness defects. These surgical knives are designed for use in eye surgery procedures.
Approximately 14,216 units have been distributed nationwide in the United States and internationally. The affected lot numbers are: 16F1KH, 16F1KJ, 16F1P7, 16FXNJ, and 16J9AE.
Ophthalmic knives are precision surgical instruments used during eye surgeries. A knife with sharpness defects may not perform as intended during surgical procedures, potentially affecting the quality and safety of the operation.
Healthcare providers should check their inventory for the affected lot numbers. Those with concerns should contact Alcon Research LLC. The FDA is monitoring this recall.
The recalled product
- Product
- Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Affected units
- 14,216
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 (7)
- Model/Catalog Number: 8065911901
- UDI-DI: 00380659119019
- Lot numbers: 16F1KH
- 16F1KJ
- 16F1P7
- 16FXNJ
- 16J9AE.
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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