Alcon Ophthalmic Surgical Knives Recalled Due to Sharpness Defects
Alcon is recalling ClearCut SB INTREPID 2.2 ANG ophthalmic surgical knives due to increased complaint reports about inadequate blade sharpness. The recall affects 35,199 units distributed across the United States and 41 other countries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a risk-of-harm product (ophthalmic surgical instrument) where no injuries have been reported. The recall is based on complaint reports regarding inadequate blade sharpness. FDA Class II classification indicates moderate regulatory concern.
Plain-English summary
Alcon Research LLC is recalling the ClearCut SB INTREPID 2.2 ANG ophthalmic knife (Model 8065992445), a surgical instrument used in ophthalmic procedures. The recall involves 35,199 units of the following lot numbers: 169P2R, 16AV06, 16AV1Y, 16F1JU, 16K9HA, and 167R42.
Alcon has detected an increase in complaint reports related to inadequate blade sharpness of these surgical instruments. Ophthalmic knives that lack proper sharpness may affect the safety and precision of surgical procedures.
The recalled units were distributed nationwide in the United States and to 41 additional countries worldwide.
The recalled product
- Product
- Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- Affected units
- 35,199
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 (8)
- Model/Catalog Number: 8065992445
- UDI-DI: 00380659924453
- Lot numbers: 169P2R
- 16AV06
- 16AV1Y
- 16F1JU
- 16K9HA
- 167R42.
Distribution
Part of a larger recall action
This product is one of 36 recalled by Alcon Research LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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