Alcon Recalls CENTURION FMS Packs Due to Molding Irregularity
Alcon is voluntarily removing specific lots of CENTURION FMS packs due to a molding irregularity that may reduce vacuum in the aspiration line.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall for a potential functional defect (reduced vacuum) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Alcon Research, Ltd. is conducting a voluntary medical device removal for specific lots of its CENTURION FMS (Fluidics Management System) packs. These packs are used with the CENTURION Vision System and identified Custom Paks.
The recall is due to the possible presence of a molding irregularity within the aspiration luer. This defect may result in a reduction of vacuum within the aspiration line.
The affected units were distributed in the US and numerous international locations, including Argentina, Australia, Canada, China, Germany, Japan, and the United Kingdom. Consumers and healthcare providers should check their lot numbers against the list provided by the FDA and contact Alcon for further instructions.
The recalled product
- Product
- CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
- Manufacturer
- Alcon Research, Ltd.
- Hazard
- Affected units
- 156,712
Distribution
Distribution scope not specified by the agency.
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