Ophthalmic surgical knives recalled due to reported sharpness defects
Alcon is recalling specific ophthalmic surgical knives due to reported sharpness defects. The recall affects 3,791 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 medical device with reported increase in complaints related to sharpness. No injuries or illnesses are mentioned in the source. This is a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion per the rubric.
Plain-English summary
Alcon Research LLC is recalling ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic surgical knives (Model 8065751767) due to reported issues with blade sharpness. The recall affects 3,791 units.
Alcon has detected an increase in complaint reports related to sharpness for these affected surgical instruments. The knives have been distributed nationwide in the United States and internationally to over 50 countries.
Affected units can be identified by the following lot numbers: 16C9ND, 16C9NE, 16C9NF, 16HE5R, and 16HYDK.
The recalled product
- Product
- Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- blade-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 (7)
- Model/Catalog Number: 8065751767
- UDI-DI: 380657517671
- Lot numbers: 16C9ND
- 16C9NE
- 16C9NF
- 16HE5R
- 16HYDK.
Distribution
Distributed nationwide across the United States.
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