FDA applicant

Allergan, Inc.

Irvine, CA47 decisions1979–202117 recalls

FDA records 47 decisions for Allergan, Inc. (Irvine, CA) from 1979 to 2021: 38 510(k) clearances, 1 De Novo grant and 8 original PMA approvals. Most are in product codes LPN (Accessories, Soft Lens Products) and HPX (Lens, Contact (Polymethylmethacrylate)). Its devices cite 27 predicates, 9 of them its own earlier devices. 17 recalls are linked to its devices, 5 Class I.

FDA’s records also spell it “Allergan”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Allergan, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007high 3 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2023

2007high 9 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Allergan, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Allergan, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

LPNAccessories, Soft Lens Products12decisions
HPXLens, Contact (Polymethylmethacrylate)8decisions
LMHImplant, Dermal, For Aesthetic Use3decisions
LCJTissue Expander And Accessories3decisions
HQCUnit, Phacofragmentation3decisions
FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2decisions

Also: HNO (2), QBR (2), KYF (1), KYG (1), MRD (1), EIB (1).

Whose devices does it build on?

Its devices cite 27 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 30 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

K981116Sovereign Cataract Extraction SystemAllergan, Inc. · 19989cite it
K961242Amo Phacoflex II Intersection SystemAllergan, Inc. · 19964cite it
K992028Refresh Contacts Lubricating and Rewetting DropsAllergan, Inc. · 19993cite it
K143354Natrelle 133 Plus Tissue ExpanderAllergan, Inc. · 20152cite it
K003638Mojave Cataract Extraction SystemAllergan, Inc. · 20012cite it
K123128Seri Surgical ScaffoldAllergan · 20132cite it

What has FDA decided for it lately?

K203229NATRELLE INSPIRA Single Use Sizers for Gel ImplantsAllergan · 2021
K193589TrueTear Intranasal Tear NeurostimulatorAllergan · 2020
K190674REFRESH RELIEVA For CONTACTSAllergan, Inc. · 2019
K180826Natrelle 133 Plus MICROCELL Tissue ExpanderAllergan · 2018
K182054Natrelle 133S Tissue ExpanderAllergan · 2018
DEN170086TrueTear Intranasal Tear NeurostimulatorAllergan · 2018
K161457XEN Glaucoma Treatment SystemAllergan, Inc. · 20161 recall
K143354Natrelle 133 Plus Tissue ExpanderAllergan, Inc. · 20151 Class I recall

All 35 as Allergan, Inc. →All 12 as Allergan →

What has been recalled?

17 recalls linked to its devices; the latest:

K981116AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.Sep 26, 2023Class II
K992028REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) SterileDec 29, 2020Class II
P990074Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP…Nov 6, 2019Class III
P020056Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10…Nov 6, 2019Class III
P020056Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes…Nov 6, 2019Class III
K161457XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other…Oct 30, 2019Class II

Other applicant names beginning “Allergan”

FDA records each applicant name separately; these may or may not be the same firm.

Allergan Medical Optics 7 Allergan Humphrey 3 Allergan Optical 2 Allergan Medical 1 Allergan Pharmaceuticals, Inc. 1