Alcon Ophthalmic Surgical Knives Recalled for Inadequate Sharpness Defect
Alcon is recalling specific ophthalmic knives due to reports of inadequate sharpness. The affected instruments may not function 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 a Class II medical device recall involving surgical instruments where inadequate sharpness poses a risk to proper surgical performance. No patient injuries or deaths have been reported. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alcon Research LLC is recalling specific lots of ClearCut and A-OK brand ophthalmic knives, surgical instruments used in eye surgery. The recall affects 29,814 units distributed nationwide and internationally.
The company detected an increase in complaint reports related to inadequate sharpness in specific models of Dual Bevel Sideport and Comeal/Scleral V-Lance ophthalmic knives. Inadequate sharpness may affect the instruments' ability to perform precisely during ophthalmic surgical procedures.
The affected devices have been distributed nationwide in the United States and to 47 countries worldwide. Healthcare facilities and eye surgery centers that received these instruments should immediately stop using the recalled lots and contact Alcon for replacement or instructions.
Patients who have concerns about procedures performed with these instruments should consult their eye care provider. The full list of affected lot numbers is available through the FDA recall notice.
The recalled product
- Product
- Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 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 (20)
- Model/Catalog Number: 8065772445
- UDI-DI: 00380657724451
- Lot numbers: 15V018
- 15V019
- 15V01A
- 15V01C
- 15V01D
- 15V036
- 15W7UE
- 15W7UF
- 15W7UH
- 15W7UJ
- 15W996
- 15W997
- 161960
- 161961
- 161962
- 161963
- 167PR0
- 167PT9
Distribution
Distributed nationwide across the United States.
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