Manufacturer

AMO Puerto Rico Manufacturing, Inc.

19 recalls in our database name AMO Puerto Rico Manufacturing, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 19
Critical: 0
Severe: 0
Most recent: 2026-04-01

Of the 19 recalls from AMO Puerto Rico Manufacturing, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–19 of 19

HighFDA (Devices)·Z-1634-2026·2026-04-01
TECNIS Eyhance intraocular lens haptic may stick to the optic
AMO Puerto Rico Manufacturing is recalling TECNIS Eyhance IOLs with the TECNIS Simplicity Delivery System because a limited quantity may have a haptic that sticks to the optic, preventing consistent unfolding.
Product
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2279-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2280-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2287-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2272-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2276-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2281-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2271-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2285-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2284-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2275-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2286-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2277-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2274-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2278-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2283-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2273-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2282-2014·2014-08-27
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1123-2014·2014-03-12
AMO TECNIS CL Foldable Silicone IOLs Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 169 units of TECNIS CL Foldable Silicone IOLs because they may be labeled with the incorrect diopter power.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide