Abbott Recalls Healon V Due to Possible Microscopic Glass Particles
Abbott Medical Optics is recalling Healon V due to a remote possibility of microscopic glass particles from manufacturing damage.
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, and the hazard is described as a 'remote possibility' rather than a confirmed defect.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling 293,867 units of Healon V, Part No. 10290045. The recall is being conducted because of a remote possibility that certain solutions in these lots may contain microscopic glass particles. This potential contamination is attributed to damage that occurred at the cylinder neck during the manufacturing process.
The affected product is distributed in the United States and worldwide, including numerous countries in Europe, Asia, the Middle East, and the Americas. The specific lot code associated with this recall is UB32491.
Consumers and healthcare providers should stop using the affected product and contact Abbott Medical Optics for further instructions or a replacement.
The recalled product
- Product
- Healon V, Part No. 10290045
- 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)
- UB32491
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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