Ophthalmic knives recalled for insufficient sharpness in surgical instruments
Alcon is recalling specific ophthalmic knives due to an increase in complaints regarding insufficient sharpness. Affected units may not perform as intended during surgical procedures.
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 an FDA Class II recall involving a defective surgical instrument with no reported injuries or illnesses. The insufficient blade sharpness constitutes a potential risk-of-harm in surgical settings, placing it at score 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Alcon Research LLC has initiated a recall of specific ClearCut and A-OK ophthalmic knives used in eye surgery. The recall was triggered by an increase in complaint reports regarding insufficient sharpness in affected units. The recalled instruments include the CLEARCUT SLIT FULL HANDLE 2.6MM ANG DUAL model (catalog number 8065992647, lot number 15X5KP).
The recall affects 5,487 units distributed nationwide in the United States and internationally to multiple countries including Canada, United Kingdom, Australia, Japan, and others.
Healthcare facilities and eye care professionals using these instruments should discontinue use of affected units and contact Alcon for replacement or instructions. Patients who may have undergone procedures using these knives should consult their healthcare provider if they have concerns about surgical outcomes.
The recalled product
- Product
- Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number: 8065992647 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- 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 (3)
- Model/Catalog Number: 8065992647
- UDI-DI: 00380659926471
- Lot number: 15X5KP.
Distribution
Distributed nationwide across the United States.
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