FDA Device Registration & Listing · Puurs-Sint-Amands Antwerpen, BE · Registration 3015456951
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| POE | Extended Depth Of Focus Intraocular Lens | Ophthalmic | Class 3 | 886.3600 | 2007-11-21 |
| MFK | Lens, Multifocal Intraocular | Ophthalmic | Class 3 | 886.3600 | 2007-11-21 |
| HQL | Intraocular Lens | Ophthalmic | Class 3 | 886.3600 | 2007-11-21 |
| MJP | Lens, Intraocular, Toric Optics | Ophthalmic | Class 3 | 886.3600 | 2007-11-21 |
| LZP | Aid, Surgical, Viscoelastic | Ophthalmic | Class 3 | 886.4275 | 2014-10-15 |
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2012-04-19 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Ophthalmic | Class 2 | 886.4150 | 2012-04-19 |
| HQB | Photocoagulator And Accessories | Ophthalmic | Class 2 | 886.4690 | 2012-04-19 |
| NGY | Cannula, Trocar, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2012-04-19 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1977-12-30 |
| MRJ | Ring, Endocapsular | Unknown | Class 3 | N/A | 2014-06-16 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1977-12-30 |
| HJI | Lens, Fundus, Hruby, Diagnostic | Ophthalmic | Class 1 | 886.1395 | 2017-09-27 |
| NGY | Cannula, Trocar, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2009-04-16 |
| HOC | Clip, Iris Retractor | Ophthalmic | Class 1 | 886.4350 | 2017-09-27 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1977-12-30 |
| HQC | Unit, Phacofragmentation | Ophthalmic | Class 2 | 886.4670 | 2007-12-13 |
| MLZ | Vitrectomy, Instrument Cutter | Ophthalmic | Class 2 | 886.4150 | 2007-12-13 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | Ophthalmic | Class 2 | 886.4100 | 2007-12-13 |
| HNN | Knife, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1994-02-03 |
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1994-02-03 |
| LZP | Aid, Surgical, Viscoelastic | Ophthalmic | Class 3 | 886.4275 | 2014-10-15 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2002-04-15 |
| KYF | Implant, Eye Valve | Ophthalmic | Class 2 | 886.3920 | 2010-03-02 |
No official correspondent registered.
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3013497605 | Alcon Research, LLC | Sinking Spring, PA, US |
| 3003701944 | OPTONOL, LTD | NEVE ILAN Central, IL |
| 3016232028 | LUMITHERA, INC. | Fort Worth, TX, US |
| 3006186389 | CIBA VISION JOHOR SDN.BHD., | GELANG PATAH, JOHOR DARUL TAKZIM, MY |
| 3016075957 | IVANTIS, INC. | Irvine, CA, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K854401 | Microsurgical Technology, Inc. | THE NEW MOBILE TIP MCINTYRE CANNULA | 1985-12-30 |
| K091915 | Lenstec, Inc. | FLUID ISOLATION DEVICE | 2009-10-27 |
| K830812 | Alphamedix, Inc. | ALPHAMEDIX I/A HAND-PIECE, 500-001 | 1983-06-08 |
| K133115 | Abbott Medical Optics, Inc. | COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK | 2014-02-27 |
| K121721 | Abbott Medical Optics, Inc. | LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) | 2012-10-15 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0275-2012 | Abbott Medical Optics Inc (AMO) | 3 | Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter.
The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag. |
| Z-0276-2012 | Abbott Medical Optics Inc (AMO) | 3 | Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter.
The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag. |
| Z-0605-2010 | Abbott Medical Optics Inc (AMO) | 3 | AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00) |
| Z-0929-2013 | Abbott Medical Optics Inc (AMO) | 3 | AMO Sensar Intraocular Lenses (IOLs), Model AR40e,
Sensar Foldable IOL with OptiEdge
Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction. |
| Z-2287-2020 | Alcon Research LLC Aspex Facility | 3 | Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3016942176 | BIOTECH EUROPE MEDITECH INC LTD | Roscommon, IE |
| 3007530141 | Alcon Research, LLC | Lesage, WV, US |
| 3002807314 | Synergy Health Ireland Ltd | Tullamore Offaly, IE |
| 9681121 | PT. CIBA VISION BATAM | BATAM ISLAND Riau, ID |
| 3012236936 | Johnson & Johnson Surgical Vision, Inc. | Irvine, CA, US |
3015456951 when referencing this establishment in official correspondence.