Ophthalmic Knives Recalled for Sharpness Defects
Alcon recalls A-OK ophthalmic knives for sharpness defects. Approximately 30,268 units distributed nationwide and internationally are affected.
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 surgical instrument with detected performance defects affecting blade sharpness. No injuries have been reported, but the defect poses risk of harm during ophthalmic surgery.
Plain-English summary
Alcon Research LLC is recalling A-OK SATINSLIT ophthalmic knives (Model 8065992761) used in eye surgery. Approximately 30,268 units have been distributed nationwide and in 48 additional countries.
The company detected an increase in complaint reports related to sharpness on the affected knives. Inadequate or inconsistent blade sharpness could compromise surgical performance during eye procedures.
Healthcare facilities and surgical centers that use these knives should discontinue use of affected units. The affected lot numbers are 1636XM, 16EV4H, 1618VR, 167PWV, and 16J7VA. Contact Alcon Research LLC for replacement or further instructions.
The recalled product
- Product
- Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- blade-sharpness-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 (7)
- Model/Catalog Number: 8065992761
- UDI-DI: 00380659927614
- Lot numbers: 1636XM
- 16EV4H
- 1618VR
- 167PWV
- 16J7VA.
Distribution
Distributed nationwide across the United States.
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