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AMO Puerto Rico Manufacturing, Inc. recalls AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for pri
Recalled March 12, 2014 · FDA recall Z-1123-2014 · AMO Puerto Rico Manufacturing
Hazard
Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power. · FDA Class II
Units
169 units
Sold at
Worldwide Distribution-USA (nationwide) and the countries of Australia, Great Britain, Canada and Japan.
Description
Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.
Product
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.
Manufacturer(s)
AMO Puerto Rico Manufacturing, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →