AMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because units may be labeled with the incorrect diopter power.
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 minor labeling error (incorrect diopter power) without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
AMO Puerto Rico Manufacturing, Inc. is recalling 77,055 units of AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. The recall is due to a labeling error where units may be labeled with the incorrect diopter power.
The affected products are indicated for primary implantation for the visual correction of aphakia in adult patients. The specific diopter sizes involved are 10.0 and 10.5. The distribution pattern includes nationwide distribution in the USA and Puerto Rico, as well as foreign distribution to Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
Consumers and healthcare providers should check their inventory against the specific lot codes provided in the official recall notice. If a unit is found with an incorrect diopter label, it should not be used for implantation.
The recalled product
- Product
- AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 10.0 and 10.5 Product Usage: AMO TECNIS CL monofocal foldab
- Manufacturer
- AMO Puerto Rico Manufacturing, Inc.
- Hazard
- Affected units
- 77,055
Distribution
Part of a larger recall action
This product is one of 17 recalled by AMO Puerto Rico Manufacturing, Inc. 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.
See all 17 products in this recall →Related recalls
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- ModerateAMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
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- ModerateAMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
FDA (Devices) · 2014-08-27
- ModerateAMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
FDA (Devices) · 2014-08-27
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