Abbott Recalls Healon Pro Due to Possible Glass Particles
Abbott Medical Optics is recalling Healon Pro ophthalmic solutions because manufacturing damage may have introduced microscopic glass particles.
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 in an ophthalmic solution) where no injuries or illnesses have been reported, fitting the 'High' severity criteria for theoretical hazards.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling 293,867 units of Healon Pro, Part No. 10270012. 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 product was 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 UB32524.
Consumers and healthcare providers should stop using the affected product and contact Abbott Medical Optics for instructions on how to return or dispose of the units.
The recalled product
- Product
- Healon Pro, Part No. 10270012
- 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)
- UB32524
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.
See all 6 products in this recall →Related recalls
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