Abbott Recalls Mislabeled Intraocular Lenses Due to Quality Control Failure
Abbott Medical Optics is recalling 41 intraocular lenses because they were not checked prior to release, potentially resulting in mislabeled products.
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 involves a labeling error (mislabeled IOLs) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling 41 units of AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002. The recall was initiated because the lenses were not being checked prior to release, which may result in the release of mislabeled intraocular lenses (IOLs).
The affected product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag. The recall covers units distributed worldwide, including the US nationwide, Puerto Rico, Canada, Latin America, Europe, Africa, the Middle East, and Asia Pacific.
Healthcare providers and patients should verify the serial numbers of their implanted or stored lenses against the list provided in the official recall notice. If a device is found to be affected, providers should contact Abbott Medical Optics for further instructions regarding removal or replacement.
The recalled product
- Product
- AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to…
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Category
- Medical Device — Ophthalmic
- 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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