Alcon Ophthalmic Surgical Knives Recalled Over Reported Sharpness Issues
Alcon is recalling 11,676 ophthalmic surgical knives due to increased reports of sharpness defects. Affected units were distributed nationwide and internationally.
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 FDA Class II recall involves a surgical instrument with documented complaints about a functional defect (sharpness). Although no injuries have been reported, the classification and nature of the product as a risk-of-harm surgical instrument warrant a High severity rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alcon Research LLC is recalling the ClearCut SatinSlit Full Handle 3.0MM ANG ophthalmic knife, model/catalog number 8065993045. This surgical instrument is used in ophthalmological procedures.
The recall was initiated due to an increase in complaint reports related to sharpness defects in these surgical knives.
11,676 units have been distributed domestically nationwide and internationally to more than 50 countries. The affected lot numbers are 164RXE and 16F1PX.
The recalled product
- Product
- Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- sharpness-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 (4)
- Model/Catalog Number: 8065993045
- UDI-DI: 00380659930454
- Lot numbers: 164RXE
- 16F1PX.
Distribution
Distributed nationwide across the United States.
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