FDA-Device2014-03-12Class II
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.
AMO Puerto Rico Manufacturing, Inc.
Hazard
Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Australia, Great Britain, Canada and Japan.
Affected count
169 units
Manufactured in
Rd # 402, Km 4.2, Anasco, PR, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1123-2014Don't want to check this manually?
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