FDA Device Registration & Listing · CLEARWATER, FL, US · Registration 1119279
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 |
|---|---|---|---|---|---|
| MFK | Lens, Multifocal Intraocular | Ophthalmic | Class 3 | 886.3600 | 2024-10-11 |
| MJP | Lens, Intraocular, Toric Optics | Ophthalmic | Class 3 | 886.3600 | 2024-10-11 |
| HQL | Intraocular Lens | Ophthalmic | Class 3 | 886.3600 | 2008-01-17 |
| KYB | Lens, Guide, Intraocular | Ophthalmic | Class 1 | 886.4300 | 2005-04-22 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-10-26 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-10-26 |
| HQL | Intraocular Lens | Ophthalmic | Class 3 | 886.3600 | 2008-09-22 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-10-26 |
| KYB | Lens, Guide, Intraocular | Ophthalmic | Class 1 | 886.4300 | 2010-11-04 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | Ophthalmic | Class 1 | 886.4300 | 2008-01-07 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | Ophthalmic | Class 1 | 886.4300 | 2018-03-19 |
| MJP | Lens, Intraocular, Toric Optics | Ophthalmic | Class 3 | 886.3600 | 2008-03-12 |
| NAA | Lens, Intraocular, Accommodative | Ophthalmic | Class 3 | 886.3600 | 2008-03-12 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | Ophthalmic | Class 1 | 886.4300 | 2018-03-19 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-10-26 |
| LZP | Aid, Surgical, Viscoelastic | Ophthalmic | Class 3 | 886.4275 | 2023-04-07 |
| MJP | Lens, Intraocular, Toric Optics | Ophthalmic | Class 3 | 886.3600 | 2008-01-17 |
| HQL | Intraocular Lens | Ophthalmic | Class 3 | 886.3600 | 2008-01-17 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-10-26 |
| HQL | Intraocular Lens | Ophthalmic | Class 3 | 886.3600 | 2008-01-17 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-10-26 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | Ophthalmic | Class 1 | 886.4300 | 2016-12-20 |
| POE | Extended Depth Of Focus Intraocular Lens | Ophthalmic | Class 3 | 886.3600 | 2023-04-27 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | Ophthalmic | Class 1 | 886.4300 | 2016-12-20 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-10-26 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1920664 | Bausch & Lomb Incorporated | Saint Louis, MO, US |
| 1032500 | Bausch & Lomb Incorporated | GREENVILLE, SC, US |
| 3007583964 | TOTAL TITANIUM, INC. | Red Bud, IL, US |
| 1281950 | Bausch & Lomb Incorporated | WILMINGTON, MA, US |
| 1315522 | Bausch & Lomb Incorporated | Lancaster, NY, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K823222 | American Medical Optics | INTRAOCULAR LENS GUIDE | 1982-12-28 |
| K133079 | Alden Optical Labs., Inc. | IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC) | 2013-12-17 |
| K941998 | Ocu-Ease Optical Products, Inc. | OCU-FLEX-38 (POLYMACON) | 1994-10-13 |
| K992500 | Cantor & Silver , Ltd. | CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS | 1999-08-18 |
| K984098 | Adventures IN Color Technology, Ltd. | ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS | 1999-05-10 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0028-2022 | Johnson & Johnson Surgical Vision Inc | 3 | TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery. |
| 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. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3012236936 | Johnson & Johnson Surgical Vision, Inc. | Irvine, CA, US |
| 2648035 | AMO PUERTO RICO MANUFACTURING, INC | ANASCO, PR, US |
| 3015456951 | Alcon Laboratories Belgium | Puurs-Sint-Amands Antwerpen, BE |
| 9612169 | ALCON LABORATORIES IRELAND LTD. | CORK, IE |
| 3007530141 | Alcon Research, LLC | Lesage, WV, US |
1119279 when referencing this establishment in official correspondence.