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Amo Puerto Rico Manufacturing, Inc

United Statesfrom the FDA registration address FDA establishment FEI 2648035

Devices
0
Registrations
FDA
FDA recalls
191 ongoing

No devices from this company are in the catalogue yet.

Company details

FDA FEI number
2648035
Address
Road 402 N., Industrial Park, ANASCO, PR, 00610

FDA recalls19

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 1

18 initiated before 2017

Showing the 10 most recent of 19 recalls.

  • 2026

    • 19 Feb 2026 Z-1634-2026 Class II Ongoing Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected. Distribution: U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI. Submission numbers: P980040, P980040S117
  • 2014

    • 13 May 2014 Z-2271-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
    • 13 May 2014 Z-2272-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
    • 13 May 2014 Z-2273-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
    • 13 May 2014 Z-2274-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
    • 13 May 2014 Z-2275-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
    • 13 May 2014 Z-2276-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
    • 13 May 2014 Z-2277-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
    • 13 May 2014 Z-2278-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
    • 13 May 2014 Z-2279-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
Show all 19 recalls
  • 2014

    • 13 May 2014 Z-2280-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
    • 13 May 2014 Z-2281-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
    • 13 May 2014 Z-2282-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
    • 13 May 2014 Z-2283-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
    • 13 May 2014 Z-2284-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
    • 13 May 2014 Z-2285-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
    • 13 May 2014 Z-2286-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
    • 13 May 2014 Z-2287-2014 Class II Terminated Units may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe,…
      Full distribution text Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
      Submission number: P880081
    • 28 Jan 2014 Z-1123-2014 Class II Terminated Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power. Distribution: Worldwide Distribution-USA (nationwide) and the countries of Australia, Great Britain, Canada and Japan. Submission number: P880081

This is an FDA establishment record without devices in deviCERTS.