FDA (Devices) recall action 68346

AMO Puerto Rico Manufacturing, Inc. recalled 17 products on 2014-08-27

The FDA (Devices) publishes a recall like this one as 17 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 17 pages.

Products: 17
Announced: 2014-08-27
Critical: 0
Units: 1,232,880

Why these products were recalled

Units may be labeled with the incorrect diopter power.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–17 of 17

ModerateFDA (Devices)··2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
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 IOL
Category
Distribution
1 state
ModerateFDA (Devices)··2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
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: 17.5, 18.0 Product Usage: AMO TECNIS CL monofocal foldable
Category
Distribution
1 state
ModerateFDA (Devices)··2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
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: 18.5-19.0 Product Usage: AMO TECNIS CL monofocal foldable I
Category
Distribution
1 state
ModerateFDA (Devices)··2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.
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: 29, 29.5 & 30. Product Usage: AMO TECNIS CL monofocal folda
Category
Distribution
1 state
ModerateFDA (Devices)··2014-08-27
AMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because units may be labeled with the incorrect diopter power.
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: 10.0 and 10.5 Product Usage: AMO TECNIS CL monofocal foldab
Category
Distribution
1 state
ModerateFDA (Devices)··2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.
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: 14.5, 15.0 Product Usage: AMO TECNIS CL monofocal foldable
Category
Distribution
1 state
ModerateFDA (Devices)··2014-08-27
AMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because they may be labeled with the incorrect diopter power.
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: 19.5-20 Product Usage: AMO TECNIS CL monofocal foldable IOL
Category
Distribution
1 state
ModerateFDA (Devices)··2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
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: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 Product Usa
Category
Distribution
1 state
ModerateFDA (Devices)··2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
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: 24.5, 25, 25.5 & 26. Product Usage: AMO TECNIS CL monofocal
Category
Distribution
1 state
ModerateFDA (Devices)··2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling specific Tecnis CL intraocular lenses because they may be labeled with the incorrect diopter power.
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: 23, 23.5 & 24. Product Usage: AMO TECNIS CL monofocal folda
Category
Distribution
1 state
ModerateFDA (Devices)··2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
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: 13.0, 13.5, 14.0 Product Usage: AMO TECNIS CL monofocal fol
Category
Distribution
1 state
ModerateFDA (Devices)··2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 intraocular lenses that may be labeled with the incorrect diopter power.
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: 26.5, 27, 27.5 & 28.5. Product Usage: AMO TECNIS CL monofoc
Category
Distribution
1 state
ModerateFDA (Devices)··2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.
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: 15.5, 16.0 Product Usage: AMO TECNIS CL monofocal foldable
Category
Distribution
1 state
ModerateFDA (Devices)··2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.
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: 12.0 and 12.5 Product Usage: AMO TECNIS CL monofocal foldab
Category
Distribution
1 state
ModerateFDA (Devices)··2014-08-27
AMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because units may be labeled with the incorrect diopter power.
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: 16.5, 17.0 Product Usage: AMO TECNIS CL monofocal foldable
Category
Distribution
1 state
ModerateFDA (Devices)··2014-08-27
AMO TECNIS CL Foldable Silicone IOLs Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.
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: 21.5-22.5 Product Usage: AMO TECNIS CL monofocal foldable I
Category
Distribution
1 state
ModerateFDA (Devices)··2014-08-27
AMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because units may be labeled with the incorrect diopter power.
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: 11.0 and 11.5 Product Usage: AMO TECNIS CL monofocal foldab
Category
Distribution
1 state