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 regarding 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 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 lenses are indicated for primary implantation for the visual correction of aphakia in adult patients. The specific diopter sizes involved in this recall are 24.5, 25, 25.5, and 26. The devices are intended to be placed in the capsular bag after cataract removal.
The recall covers units distributed worldwide, including the United States, Puerto Rico, Latin America, Asia Pacific, Canada, Europe, Africa, the Middle East, and Japan. Healthcare providers and patients should verify the diopter power of the lenses against the surgical plan to ensure the correct power is implanted.
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: 24.5, 25, 25.5 & 26. Product Usage: AMO TECNIS CL monofocal
- 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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