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 Certain Silicone TECNIS IOLs may be labeled with...
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, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients.
Quantity: 169 units
Why Was This Recalled?
Certain Silicone TECNIS IOLs 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.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report