AMO Puerto Rico Manufacturing, Inc.

FDA Regulatory Profile

Summary

Total Recalls
18
510(k) Clearances
0
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2275-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-2273-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-2277-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-2287-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-2272-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-2282-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-2271-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-2278-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-2280-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-2283-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-2274-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-2281-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-2279-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-2285-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-2276-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-2286-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-2284-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantMay 13, 2014
Z-1123-2014Class IIAMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. January 28, 2014