Alcon Ophthalmic Knives Recalled Due to Sharpness Defect Complaint Increase
Alcon is recalling ClearCut and A-OK Corneal/Scleral ophthalmic knives due to increased complaints about sharpness. The recall affects 6,972 units 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 an FDA Class II medical device recall involving surgical knives with sharpness defects. No injuries or deaths have been reported, but the defect affects the safety-critical function of these instruments in eye surgery, meeting the rubric criterion for risk-of-harm products where injury has not yet been documented.
Plain-English summary
Alcon Research LLC is recalling specific lots of ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic knives due to an increase in complaint reports related to sharpness. These are surgical instruments used in eye procedures.
The affected product lot numbers are 16A6HW, 16A6HX, 16A6HY, 16AUNE, 16C9R3, 16HYFF, and 16HYFJ. A total of 6,972 units are involved in this recall.
The affected knives have been distributed domestically throughout the United States and internationally to numerous countries including Canada, the United Kingdom, Australia, and others. Consumers and healthcare providers in these regions should check whether they have affected units.
If you have received or are using one of the affected ophthalmic knives, contact Alcon Research LLC for instructions on product replacement or return.
The recalled product
- Product
- Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- sharpness-defect
- surgical-device-safety
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 (9)
- Model/Catalog Number: 8065753106
- UDI-DI: 380657531066
- Lot numbers: 16A6HW
- 16A6HX
- 16A6HY
- 16AUNE
- 16C9R3
- 16HYFF
- 16HYFJ.
Distribution
Distributed nationwide across the United States.
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