Alcon ophthalmic surgical knives recalled for sharpness defects
Alcon Research LLC recalls ClearCut and A-OK ophthalmic surgical knives due to increased reports of sharpness issues that may affect surgical performance.
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. While no reported injuries or adverse events are documented, surgical instruments with sharpness defects present a risk-of-harm during critical ocular procedures, warranting High severity classification.
Plain-English summary
Alcon Research LLC is recalling specific lots of ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance ophthalmic surgical knives due to increased complaint reports related to sharpness. The affected product model is 8065751618, lot 16D1KN, with 324 units involved in the recall.
These surgical knives are precision instruments used during ophthalmic procedures to make incisions during eye surgery. Defects in blade sharpness may compromise surgical precision and could extend operative time, potentially affecting the quality and safety of surgical outcomes.
The recalled instruments were distributed nationwide throughout the United States and to 49 additional countries including Canada, Mexico, Japan, Germany, and others. Healthcare facilities, surgical centers, and eye care providers that have received affected lots should immediately identify and quarantine the recalled products.
Healthcare providers and facilities should discontinue use of affected lots immediately and contact Alcon Research LLC for replacement options or disposal instructions. Patients who may have undergone recent eye surgery with these instruments are encouraged to contact their eye care provider if they experience any unexpected vision changes or complications.
The recalled product
- Product
- Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- dull-blade
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: 8065751618
- UDI-DI: 380657516186
- Lot number: 16D1KN.
Distribution
Distributed nationwide across the United States.
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