Abbott Recalls 41 Intraocular Lenses Due to Mislabeled Product Risk
Abbott Medical Optics is recalling 41 TECNIS Multifocal Intraocular Lenses because they were not checked prior to release, posing a risk of mislabeling.
What this means for you
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 involves a risk of mislabeling without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling 41 units of the TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00. The recall was initiated because the lenses were not being checked prior to release, which may result in the release of mislabeled products.
The affected lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia. The distribution pattern for these units is worldwide, including the US nationwide, Puerto Rico, Canada, Latin America, Europe, Africa, the Middle East, and Asia Pacific.
Consumers and healthcare providers should check their inventory for the specific serial numbers listed in the official recall notice. If a patient has received one of these lenses, they should contact their eye care provider for further instructions.
The recalled product
- Product
- TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extract
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Hazard
- Affected units
- 41
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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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