Ophthalmic Knives Recalled Due to Complaints About Reduced Sharpness
Alcon is recalling ophthalmic knives for increased complaints of reduced sharpness. These surgical instruments require consistent blade sharpness for surgical precision in eye procedures.
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 with no reported injuries or hospitalizations. It constitutes a risk-of-harm medical device where injury has not yet been reported. Per the severity rubric, recalls with no reported injuries and theoretical hazards are scored at most 3 (High).
Plain-English summary
Alcon Research LLC is recalling specific lot numbers of ophthalmic knives, including ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance models (Model 8065772245, ClearCut Safety Intrepid SB 2.2), following an increase in complaint reports related to reduced sharpness.
Consistent blade sharpness is critical for surgical precision during ophthalmic procedures. Reduced sharpness may compromise surgical control, prolong operative time, and potentially affect surgical outcomes.
Approximately 13,824 units were distributed nationwide in the United States and internationally to 44 other countries. Affected units can be identified by lot numbers: 15P7PW, 15TFMD, 15TFME, 15TFMF, 15W7U4, 15W7U5, 15W7U6, 15W7U7, 15W7U8, 15W993, 169KKN, 169KKP, 169KKR, 169KKT, and 169KRX.
Healthcare facilities using these instruments should verify their inventory against the provided lot numbers and contact Alcon for instructions on device replacement or corrective action.
The recalled product
- Product
- Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Number: 8065772245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- sharpness-degradation
- surgical-injury-risk
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 (17)
- Model/Catalog Number: 8065772245
- UDI-DI: 00380657722457
- Lot numbers: 15P7PW
- 15TFMD
- 15TFME
- 15TFMF
- 15W7U4
- 15W7U5
- 15W7U6
- 15W7U7
- 15W7U8
- 15W993
- 169KKN
- 169KKP
- 169KKR
- 169KKT
- 169KRX.
Distribution
Distributed nationwide across the United States.
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