AMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because they 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) with no reported injuries or illnesses in the source text.
Plain-English summary
AMO Puerto Rico Manufacturing, Inc. is recalling 77,055 units of the AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. The recall is due to a labeling error where the units may be marked with the incorrect diopter power.
The affected devices are monofocal foldable intraocular lenses indicated for primary implantation for the visual correction of aphakia in adult patients. The recall covers units distributed worldwide, including the United States, Puerto Rico, Canada, Latin America, Asia Pacific, Europe, Africa, the Middle East, and Japan.
Patients who have received these lenses should consult their eye care provider to verify the correct diopter power of the implanted device. The source text does not specify a consumer action for unimplanted lenses, but the labeling error affects the accuracy of the device's optical power specification.
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: 19.5-20 Product Usage: AMO TECNIS CL monofocal foldable IOL
- 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
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