Abbott Recalls Mislabeled AMO Sensar Intraocular Lenses
Abbott Medical Optics is recalling 155 AMO Sensar Intraocular Lenses because two production orders contained mislabeled units. The lenses are distributed worldwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is identified as mislabeling. Per the rubric, minor labeling errors or voluntary precautionary recalls without reported injuries are typically scored as Moderate (2).
Plain-English summary
Abbott Medical Optics Inc (AMO) is recalling 155 units of AMO Sensar Intraocular Lenses (IOLs), Model AR40e. These are ultraviolet-absorbing posterior chamber intraocular lenses used after cataract extraction. The recall involves two production orders that contain mislabeled IOLs.
The affected lenses were distributed worldwide, including the United States (nationwide, including Ohio) and the countries of Germany, Switzerland, Sweden, Italy, China, France, Singapore, UK, Croatia, Hungary, Turkey, and Brazil. The specific lot codes and diopter values (18.0 and 23.5) are listed in the agency's structured data.
Consumers and healthcare providers should check their inventory for the specific lot codes and diopter values listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.
- Manufacturer
- Abbott Medical Optics Inc (AMO)
- Hazard
- Affected units
- 155
Distribution
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