FDA Recalls Alcon Ophthalmic Knives for Decreased Blade Sharpness
Alcon is recalling 1,061 ophthalmic surgical knives due to reports of decreased sharpness. The affected instruments are used in eye surgery procedures and may not perform as intended.
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 recall of surgical instruments with documented performance defects, but no reported illnesses or injuries. The instruments are used in critical eye surgery procedures, and a performance defect poses a risk of harm despite no incidents being reported to date. This fits the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alcon Research LLC is recalling model 8065000093 ophthalmic surgical knives, specifically the ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance models. The recall affects 1,061 units with lot number 16HY6X. These instruments were distributed domestically throughout the United States and internationally to 48 countries.
Alcon has identified an increase in complaint reports related to decreased sharpness in these surgical knives. These instruments are precision tools used in ophthalmic surgery, and degraded sharpness may compromise their intended performance during surgical procedures.
The FDA has classified this as a Class II recall. Healthcare facilities and surgical centers that have received these instruments should verify their inventory against the recalled lot number and contact Alcon Research LLC for further instructions regarding use and disposition of the affected knives.
The recalled product
- Product
- Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- blade-dullness
- surgical-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 (3)
- Model/Catalog Number: 8065000093
- UDI-DI: 380650000934
- Lot numbers: 16HY6X.
Distribution
Distributed nationwide across the United States.
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