Abbott Recalls Healon Medical Device Due to Glass Particle Risk
Abbott Medical Optics is recalling Healon medical devices because certain lots may contain 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 (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 specific lots of Healon, a medical device used in ophthalmic procedures. The recall involves 293,867 units distributed in the United States and worldwide, including numerous countries in Europe, Asia, and South America.
The recall was initiated due to 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.
Consumers and healthcare providers should check their inventory for the specific part numbers and lot codes listed in the official recall notice. If the product is found, it should be removed from use and returned to Abbott Medical Optics or the distributor in accordance with the recall instructions.
The recalled product
- Product
- Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
- 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 (10)
- UB32602
- UB32593
- UB32514
- UB32521
- UB32579
- UB32573
- UB32599
- UB32614
- UB32616
- UB32533
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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