Ophthalmic Surgical Knives Recalled for Reduced Sharpness in Eye Surgery
Alcon Research LLC is recalling 2,520 CLEARCUT HP2 DB ophthalmic knives due to increased reports of reduced sharpness. The affected lot 164RY1 was 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: This is classified as FDA Class II with no reported injuries or illnesses. The hazard relates to surgical instrument performance (reduced sharpness) which poses potential risk during delicate eye surgery procedures but has not resulted in documented patient harm. This meets the criteria for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Alcon Research LLC is recalling ophthalmic knives (CLEARCUT HP2 DB SLIT 3.0MM model 8065983065) due to reports of reduced sharpness. The affected lot number is 164RY1, and approximately 2,520 units were distributed nationwide in the United States and internationally to countries including Canada, Australia, Japan, and others.
The company detected an increase in complaint reports related to sharpness for the ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance ophthalmic knives. These are surgical instruments used in eye surgery procedures.
Ophthalmic surgeons and surgical centers should review their inventory for the affected lot number (164RY1). If you have these knives in use or in stock, contact Alcon Research LLC for information about the recall. Healthcare providers should report any problems with this product to the FDA through its MedWatch program.
The recalled product
- Product
- Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- reduced-sharpness
- surgical-instrument-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 (3)
- Model/Catalog Number: 8065983065
- UDI-DI: 00380659830655
- Lot number: 164RY1.
Distribution
Distributed nationwide across the United States.
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