FDAFDA · Food and drugs·Recall number Z-2271-2014
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: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 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.
Published August 27, 2014 · Recall initiated: May 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Units may be labeled with the incorrect diopter power.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AMO Puerto Rico Manufacturing, Inc.
- Distributor
- Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
- Lot
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- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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