AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling specific 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 labeling error (incorrect diopter power) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
AMO Puerto Rico Manufacturing, Inc. is recalling AMO TECNIS CL Foldable Silicone IOLs with OptiEdge Design, Model Z9002. The recall is due to a labeling error where units may be marked with the incorrect diopter power.
The affected products are monofocal foldable intraocular lenses indicated for primary implantation for the visual correction of aphakia in adult patients. The recall covers specific serial numbers listed in the official notice, with distribution reported as worldwide, including the United States, Puerto Rico, and various international regions.
Patients who have received these lenses should contact their eye care provider to verify the correct diopter power of the implanted device. No specific instructions for consumer action are provided in the source text beyond the identification of the defect.
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: 23, 23.5 & 24. Product Usage: AMO TECNIS CL monofocal folda
- Manufacturer
- AMO Puerto Rico Manufacturing, Inc.
- Hazard
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
Same manufacturer · AMO Puerto Rico Manufacturing, Inc.
See all →- HighTECNIS Eyhance intraocular lens haptic may stick to the optic
FDA (Devices) · 2026-04-01
- ModerateAMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
FDA (Devices) · 2014-08-27
- ModerateAMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
FDA (Devices) · 2014-08-27
- ModerateAMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
FDA (Devices) · 2014-08-27
- ModerateAMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
FDA (Devices) · 2014-08-27
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02