Ophthalmic Surgical Knives Recalled Due to Sharpness Defect
Alcon is recalling 7,713 units of ClearCut and A-OK ophthalmic surgical knives due to reports of decreased sharpness. The defect may compromise surgical performance during eye 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: These are high-risk surgical instruments used in ophthalmic procedures. The sharpness defect poses risk of harm to surgical outcome and precision, but no illnesses or injuries have been reported. This meets the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alcon Research LLC is recalling 7,713 units of ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic surgical knives (Model 8065000095). The affected devices are identified by the following lot numbers: 16D1KR, 16D1KU, 16D1KV, 16D1KW, 16D1KX, 16FX1P, 16FX1R, 16HYDY, 16HYE0, and 16HYE1.
Alcon has detected an increase in complaint reports related to sharpness of the affected surgical knives. Instruments with reduced sharpness may compromise surgical performance during ophthalmic procedures and affect surgical precision.
The recalled devices were distributed nationwide in the United States and internationally to multiple countries including Canada, Mexico, and locations throughout Europe, Asia, South America, Australia, and the Middle East.
Healthcare facilities using or storing any of the recalled instruments should verify their inventory against the affected lot numbers and contact Alcon Research LLC for guidance on this recall.
The recalled product
- Product
- Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component: N/A
- Manufacturer
- Alcon Research LLC
- Affected units
- 7,713
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 (12)
- Model/Catalog Number: 8065000095
- UDI-DI: 380650000958
- Lot numbers: 16D1KR
- 16D1KU
- 16D1KV
- 16D1KW
- 16D1KX
- 16FX1P
- 16FX1R
- 16HYDY
- 16HYE0
- 16HYE1.
Distribution
Part of a larger recall action
This product is one of 36 recalled by Alcon Research LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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