Alcon Ophthalmic Surgical Knives Recalled for Inadequate Sharpness
Alcon is recalling 4,481 units of ClearCut and A-OK brand ophthalmic surgical knives due to complaint reports of inadequate sharpness. These instruments are used in eye surgery 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: FDA Class II surgical device with reported performance defects on instruments used in eye surgery. No injuries or illnesses have been reported, but dull surgical knives present a potential risk of improper surgical performance.
Plain-English summary
Alcon Research LLC is recalling 4,481 units of ophthalmic surgical knives sold under the brand names ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance. The company detected an increase in complaint reports related to sharpness, indicating potential performance issues during surgical use.
The affected knives were distributed nationwide in the United States and internationally to approximately 40 countries. The affected lot numbers are 16AUN4, 16AUN3, 16C9PX, 16C9PY, and 16C9R0 (model 8065752451).
Healthcare providers and surgical facilities should check their inventory against the affected lot numbers. Those with affected units should contact Alcon Research LLC for guidance on return or replacement. Patients who have undergone eye surgery should consult their ophthalmologist if they have concerns about their procedure.
The recalled product
- Product
- Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- inadequate-sharpness
- performance-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: 8065752451
- UDI-DI: 380657524518
- Lot numbers: 16AUN4
- 16AUN3
- 16C9PX
- 16C9PY
- 16C9R0.
Distribution
Distributed nationwide across the United States.
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