Alcon Recalls Patient Care Kits Due to Sterile Packaging Concerns
Alcon is voluntarily removing 561,702 Patient Care Kits from the US market because the supplier reported potential sterile packaging compromise.
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: The recall is classified as FDA Class II and is a voluntary precautionary removal based on a potential packaging compromise without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Alcon Research, Ltd. is initiating a voluntary medical device removal for 561,702 units of Alcon Patient Care Kits. These kits are assemblages of single-use medical devices and accessories designed for specific procedures and are configured with customer-specific components.
The recall was initiated because the product supplier stated there is a potential for the sterile packaging to be compromised. The affected products were distributed nationwide in the United States.
Healthcare providers and consumers should stop using the affected Patient Care Kits and contact Alcon for further instructions or replacement.
The recalled product
- Product
- Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components
- Manufacturer
- Alcon Research, Ltd.
- Category
- Medical Device — Surgical Kits
- Affected units
- 561,702
Distribution
Distributed nationwide across the United States.
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