Abbott Recalls Healon Duet Due to Potential Glass Particles
Abbott Medical Optics is recalling Healon Duet units because they may contain microscopic glass particles from manufacturing damage.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (microscopic glass particles) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling 293,867 units of Healon Duet, Part No. 10290080, 10220010, 10220011, and 10220012. The recall is due to a remote possibility that certain solutions in these lots may contain microscopic glass particles. This potential contamination resulted from damage that occurred at the cylinder neck during the manufacturing process.
The affected products were distributed in the US and worldwide, including locations in Europe, Asia, the Middle East, and South America. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in theory, cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected lots of Healon Duet. Consumers should contact their healthcare provider or the recalling firm for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Affected units
- 293,867
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 (1)
- UB32636
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Abbott Medical Optics Inc. (AMO) 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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