ClearCut Ophthalmic Knives Recalled for Sharpness Defect
Alcon is recalling 18,726 ClearCut ophthalmic knives worldwide due to reports of inadequate sharpness. The defect could compromise surgical precision during eye surgery.
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 recall of a risk-of-harm surgical instrument where inadequate sharpness could compromise surgical precision and patient safety. No injuries have been reported, consistent with the rubric criterion: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Alcon Research LLC is recalling 18,726 units of ClearCut ophthalmic knives due to increased reports of sharpness defects.
The manufacturer detected an increase in complaint reports related to sharpness for these surgical instruments used in eye procedures. Inadequate sharpness could compromise the precision and effectiveness of ophthalmic surgery.
The affected units were distributed throughout the United States and internationally to more than 44 countries worldwide. Specific lot numbers are identified by the FDA in recall Z-2654-2024.
Healthcare professionals and facilities should verify their ClearCut ophthalmic knife lot numbers against the FDA recall list. Customers should contact Alcon for instructions on return, exchange, or disposal of affected units.
The recalled product
- Product
- Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- blade-sharpness-defect
- surgical-precision-loss
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 (20)
- Model/Catalog Number: 8065772745
- UDI-DI: 00380657724659
- Lot numbers: 1668AM
- 1668CX
- 167PPX
- 167PPY
- 167PT5
- 168NM3
- 168NM4
- 168NMW
- 168NMX
- 169KT6
- 169KKV
- 169KT5
- 16ALNW
- 16AUL2
- 16DDRC
- 16DDY6
- 16DDY7
- 16DDYW
Distribution
Distributed nationwide across the United States.
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