Recall Z-2282-2014— AMO Puerto Rico Manufacturing, Inc.

Class II FDA medical device recall by AMO Puerto Rico Manufacturing, Inc., initiated 2014-05-13, terminated 2017-05-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 20.5-21 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.. Reason: Units may be labeled with the incorrect diopter power..

Recalling firm

AMO Puerto Rico Manufacturing, Inc.

Classification

Class II

Status

Terminated

Initiated

2014-05-13

Terminated

2017-05-18

Firm location

Anasco, PR, United States

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