Abbott Recalls Healon 5 Pro Due to Possible Glass Particles
Abbott Medical Optics is recalling Healon 5 Pro ophthalmic solution because some units 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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential physical injury without confirmed cases.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling 293,867 units of Healon 5 Pro, Part No. 10270015. 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 UB32526.
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 5 Pro, Part No. 10270015
- 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)
- UB32526
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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