Alcon ophthalmic surgical knives recalled for sharpness defects
Alcon is recalling ClearCut and A-OK ophthalmic surgical knives due to sharpness complaints. The defect affects 1,057 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: FDA Class II recall of surgical instruments with reported sharpness defects. No injuries or illnesses have been reported in the source text, making this a potential risk-of-harm product where actual injury has not yet occurred, supporting a score of 3 per the rubric.
Plain-English summary
Alcon Research LLC is recalling ophthalmic surgical knives due to reports of sharpness defects. The recall includes two product types: ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance knives. A total of 1,057 units are affected, identified by model/catalog number 8065752450 and lot number 16C9P7.
Alcon detected an increase in complaint reports related to the sharpness of these specific knives. These surgical instruments are used in eye surgery procedures and are distributed both domestically in the United States and internationally to multiple countries.
The recalled product
- Product
- Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
- Manufacturer
- Alcon Research LLC
- Affected units
- 1,057
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: 8065752450
- UDI-DI: 380657524501
- Lot number: 16C9P7.
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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