Recall archive
3 recalls · page 1 of 1
Reported Apr 1, 2026
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AMO Puerto Rico Manufacturing, Inc.
Matched: Brand — Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as…
FDA (openFDA device enforcement)
Reported Aug 27, 2014
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AMO Puerto Rico Manufacturing, Inc.
Matched: Brand · Product · Product details — Units may be labeled with the incorrect diopter power.
16 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2014
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AMO Puerto Rico Manufacturing, Inc.
Matched: Brand · Product · Product details — Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.
FDA (openFDA device enforcement)
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