Abbott Recalls Mislabeled Intraocular Lenses Due to Quality Control Failure
Abbott Medical Optics is recalling 65 units of TECNIS 1-Piece Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific hazard is mislabeling, which is a quality control issue rather than a direct physical defect causing injury.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling 65 units of TECNIS 1-Piece Intraocular Lenses, Model No. ZCB00. The recall was initiated because the devices were not being checked prior to release, which may result in the release of mislabeled IOLs.
The affected lenses are 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, Puerto Rico, Canada, Latin America, Europe, Africa, the Middle East, and Asia Pacific.
Healthcare providers and patients should check their records for the specific serial numbers listed in the recall notice. If a patient has received an affected lens, they should contact their eye care provider for further instructions.
The recalled product
- Product
- TECNIS 1-Piece IOL, Model No. ZCB00 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 be placed in the capsular bag
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Hazard
- Affected units
- 65
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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