Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design Recalled by AMO Puerto Rico Manufacturing, Inc. Due to Units may be labeled with the incorrect diopter...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact AMO Puerto Rico Manufacturing, Inc. directly.
Affected Products
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 IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
Quantity: 77,055 IOLs in total
Why Was This Recalled?
Units may be labeled with the incorrect diopter power.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About AMO Puerto Rico Manufacturing, Inc.
AMO Puerto Rico Manufacturing, Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report