Allergan, Inc.
Medical device manufacturer in Irvine, CA.
38510(k) clearances
8PMA approvals
26recalls
Device types
- LPN Accessories, Soft Lens Products 12
- HPX Lens, Contact (Polymethylmethacrylate) 8
- HQC Unit, Phacofragmentation 3
- LCJ Tissue Expander And Accessories 3
- HNO Keratome, Ac-Powered 2
- GCY Apparatus, Suction, Single Patient Use… 1
- HNR Forceps, Ophthalmic 1
- EIB Syringe, Irrigating (Dental) 1
- KYB Lens, Guide, Intraocular 1
- KYG Device, Irrigation, Ocular Surgery 1
- GWL Amplifier, Physiological Signal 1
- OXF Mesh, Surgical, Absorbable, Plastic And… 1
- KYF Implant, Eye Valve 1
- QBR Intranasal Electrostimulation Device For… 1
- MRD Mammary Sizer 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K203229 | NATRELLE INSPIRA Single Use Sizers for Gel ImplantsMRD · Special | 06/02/2021SE |
| K193589 | TrueTear Intranasal Tear NeurostimulatorQBR · Traditional | 08/31/2020SE |
| K190674 | REFRESH RELIEVA For CONTACTSLPN · Traditional | 08/08/2019SE |
| K180826 | Natrelle 133 Plus MICROCELL Tissue ExpanderLCJ · Traditional | 12/21/2018SE |
| K182054 | Natrelle 133S Tissue ExpanderLCJ · Special | 08/29/2018SE |
| K161457 | XEN Glaucoma Treatment SystemKYF · Traditional | 11/21/2016SE |
| K143354 | Natrelle 133 Plus Tissue ExpanderLCJ · Traditional | 08/20/2015SE |
| K123128 | Seri Surgical ScaffoldOXF · Traditional | 04/25/2013SE |
| K083812 | Refresh Optive Lens Comfort Rewetting DropsLPN · Traditional | 07/09/2009SE |
| K051852 | Single Amplifier for BotoxGWL · Traditional | 09/14/2005SE |
| K014202 | Complete Brand Multi-Purpose SolutionLPN · Traditional | 02/20/2002SE |
| K013479 | Complete Brand Multi-Purpose SolutionLPN · Traditional | 02/11/2002SE |
| K003252 | Complete Brand Multi-Purpose SolutionLPN · Traditional | 02/21/2001SE |
| K003638 | Mojave Cataract Extraction SystemHQC · Abbreviated | 02/13/2001SE |
| K003109 | Complete Brand Lubricating and Rewetting DropsLPN · Abbreviated | 11/21/2000SE |
| K000164 | Complete Brand Comfortplus Multi-Purpose SolutionLPN · Traditional | 06/02/2000SE |
| K992028 | Refresh Contacts Lubricating and Rewetting DropsLPN · Abbreviated | 10/07/1999SE |
| K984383 | Ultracare Neutralizing TabletsLPN · Special | 12/18/1998SE |
| K983150 | Complete Brand Lubricating and Rewetting DropsLPN · Traditional | 11/25/1998SE |
| K981168 | Complete Brand Multi-Purpose Solution, Complete Brand Lubricating and Rewetting DropsLPN · Traditional | 09/01/1998SE |
| K980775 | Complete Brand Multi-Purpose SolutionLPN · Traditional | 07/06/1998SE |
| K981116 | Sovereign Cataract Extraction SystemKYG · Traditional | 05/19/1998SE |
| K971186 | Amo Diplomax/Opsys ConsoleHQC · Traditional | 06/13/1997SE |
| K962402 | Amo Prestige Day Pack (Allergan, Inc.)HQC · Traditional | 09/19/1996SE |
| K961242 | Amo Phacoflex II Intersection SystemKYB · Traditional | 06/17/1996SE |
| K874543 | Model OPO-32 Irrigation SleeveEIB · Traditional | 01/14/1988SE |
| K870807 | BKS-1000 Refractive Set Use in KeratorefractiveHNO · Traditional | 05/29/1987SE |
| K864065 | BKS-42 Disposable Vacuum Tubing PackHNO · Traditional | 12/15/1986SE |
| K864003 | Paco-Folder (TM) Intraocular Lens ForcepsHNR · Traditional | 10/31/1986SE |
| K863201 | New Use for Acuvac Suction Reservoir 400CCGCY · Traditional | 08/29/1986SE |
| K861643 | Stylekeeper Contact Lens Carrying CaseHPX · Traditional | 06/02/1986SE |
| K861642 | Lenskeeper Contact Lens Carrying CaseHPX · Traditional | 05/29/1986SE |
| K822706 | Pre-SertHPX · Traditional | 10/22/1982SE |
| K822707 | Clean-N-SoakHPX · Traditional | 10/18/1982SE |
| K821054 | TotalHPX · Traditional | 05/13/1982SE |
| K821052 | SoakareHPX · Traditional | 05/13/1982SE |
| K821051 | Liquifilm Wetting SolutionHPX · Traditional | 05/13/1982SE |
| K821055 | Blink-N-CleanHPX · Traditional | 05/10/1982SE |
PMA approvals
- P110033 Juvederm Voluma XC · 10/22/2013 · 97 supplements
- P040046 Natrelle Highly Cohesive Silicone-Filled Breast Implants · 02/20/2013 · 29 supplements
- P020056 Natrelle Silicone-Filled Breast Implants · 11/17/2006 · 55 supplements
- P050047 Juvederm 24HV, Juvederm 30 and Juvederm 30HV Gel Implants · 06/02/2006 · 101 supplements
- P990074 Natrelle Saline Breast Implants · 05/10/2000 · 52 supplements
- P900030 Contigen (TM) Bard (R) Collagen Implant · 09/30/1993 · 9 supplements
- P800022 Zyderm Collagen Implant (Zyderm Ci) · 07/22/1981 · 45 supplements
- P790006 Angelchik Anti-Reflux Prosthesis · 10/19/1979 · 5 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0948-2021 Class II | REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) SterileMissing Instruction For Use insert. | 12/29/2020Terminated |
| Z-0702-2020 Class III | NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X…The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1… | 11/06/2019Terminated |
| Z-0701-2020 Class III | Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes:…The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1… | 11/06/2019Terminated |
| Z-0700-2020 Class III | Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10…The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1… | 11/06/2019Terminated |
| Z-0699-2020 Class III | Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP…The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1… | 11/06/2019Terminated |
| Z-0598-2020 Class II | XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other…Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on… | 10/30/2019Open, Classified |
| Z-2465-2019 Class I | Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL…The action was initiated following notification by the U.S. FDA of their recently updated, global safety… | 07/24/2019Open, Classified |
| Z-2464-2019 Class I | RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL…The action was initiated following notification by the U.S. FDA of their recently updated, global safety… | 07/24/2019Open, Classified |
| Z-2463-2019 Class I | Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML…The action was initiated following notification by the U.S. FDA of their recently updated, global safety… | 07/24/2019Open, Classified |
| Z-2462-2019 Class I | Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL…The action was initiated following notification by the U.S. FDA of their recently updated, global safety… | 07/24/2019Open, Classified |
| Z-2461-2019 Class I | Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast…The action was initiated following notification by the U.S. FDA of their recently updated, global safety… | 07/24/2019Open, Classified |
| Z-2460-2019 Class I | Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM…The action was initiated following notification by the U.S. FDA of their recently updated, global safety… | 07/24/2019Open, Classified |
| Z-2459-2019 Class I | McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast…The action was initiated following notification by the U.S. FDA of their recently updated, global safety… | 07/24/2019Open, Classified |
| Z-2458-2019 Class I | McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for…The action was initiated following notification by the U.S. FDA of their recently updated, global safety… | 07/24/2019Open, Classified |
| Z-2457-2019 Class I | Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with…The action was initiated following notification by the U.S. FDA of their recently updated, global safety… | 07/24/2019Open, Classified |
| Z-2456-2019 Class I | Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable…The action was initiated following notification by the U.S. FDA of their recently updated, global safety… | 07/24/2019Open, Classified |
| Z-2455-2019 Class I | Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan…The action was initiated following notification by the U.S. FDA of their recently updated, global safety… | 07/24/2019Open, Classified |
| Z-2454-2019 Class I | Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile…The action was initiated following notification by the U.S. FDA of their recently updated, global safety… | 07/24/2019Open, Classified |
| Z-2453-2019 Class I | Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style…The action was initiated following notification by the U.S. FDA of their recently updated, global safety… | 07/24/2019Open, Classified |
| Z-2452-2019 Class I | Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell…The action was initiated following notification by the U.S. FDA of their recently updated, global safety… | 07/24/2019Open, Classified |
| Z-2451-2019 Class I | Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for…The action was initiated following notification by the U.S. FDA of their recently updated, global safety… | 07/24/2019Open, Classified |
| Z-2104-2015 Class II | Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander…Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were… | 06/18/2015Terminated |
| Z-2103-2015 Class II | Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander…Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was… | 06/18/2015Terminated |
| Z-1988-2015 Class II | Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The…Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product… | 06/08/2015Terminated |
| Z-2123-2011 | Lap-Band Access Port Needle 10-Pack, 20 G x 51 mm (2 in.), Product Code: 8-20302-10, Lot…The recall was initiated because Allergan has determined that a number of Access Port Needle pouches from… | 03/21/2011Terminated |
| Z-0418-2011 | LAP-BAND Adjustable Gastric Band System; Product codes: B-2105 (ACCSS PRT II KIT…In a LAP-BAND System adjustment, failure to inject the needle perpendicular to the access port septum, as… | 09/16/2010Terminated |