Abbott Recalls Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling 70 units of TECNIS OptiBlue 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, and the hazard is a labeling error (mislabeled IOLs) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling 70 units of the TECNIS OptiBlue 1-Piece Intraocular Lens (IOL) with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V. The recall is being conducted because the lenses were not being checked prior to release, which may result in the release of mislabeled IOLs.
The affected products 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 specific serial numbers affected are listed in the structured product information provided by the FDA. The recall number is Z-2862-2016.
The FDA has classified this recall as Class II, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The distribution pattern for these units was worldwide, including the US, Puerto Rico, Canada, Latin America, Europe, Africa, the Middle East, and Asia Pacific. Healthcare providers and patients should verify the serial numbers of their devices against the list provided by the FDA and contact Abbott Medical Optics for further instructions.
The recalled product
- Product
- TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V 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 le
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Hazard
- Affected units
- 70
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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