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 labeling error (incorrect diopter power) rather than a structural defect or contamination. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity labeling error.
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 affected devices are monofocal foldable intraocular lenses indicated for primary implantation for the visual correction of aphakia in adult patients. The specific diopter sizes involved are 29, 29.5, and 30.
The recall was initiated because units may be labeled with the incorrect diopter power. This labeling error could result in the implantation of a lens with a power different from what was intended for the patient's visual correction.
The affected units were distributed worldwide, including in the United States, Puerto Rico, Latin America, Asia Pacific, Canada, Europe, Africa, the Middle East, and Japan. Healthcare providers and patients should verify the serial numbers of their devices against the list provided in the official recall notice to determine if they are affected.
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: 29, 29.5 & 30. Product Usage: AMO TECNIS CL monofocal folda
- 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 Power Labeling
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- ModerateAMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
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