Company ยท US
Advanced Medical Optics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2008. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
17recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 8, 2008 | K081681 | VITRECTOMY CUTTER AND ACCESSORIES Advanced Medical Optics, Inc. | MLZ |
| Oct 2, 2008 | K081545 | ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 Advanced Medical Optics, Inc. | MSS |
| Apr 7, 2006 | K060366 | THE AMO OPHTHALMIC SURGICAL SYSTEM Advanced Medical Optics, Inc. | HQC |
| Jul 29, 2005 | K042562 | LENS PLUS REWETTING DROPS Advanced Medical Optics, Inc. | LPN |
| Apr 5, 2005 | K050648 | SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK Advanced Medical Optics, Inc. | HQC |
| Oct 19, 2004 | K040839 | COMPLETE BLINK-N-CLEAN LENS DROPS Advanced Medical Optics, Inc. | MRC |
| Sep 25, 2003 | K032030 | BLINK CL LUBRICANT EYE DROPS Advanced Medical Optics, Inc. | LPN |
| Apr 4, 2003 | K030092 | COMPLETE BRAND MULTI-PURPOSE SOLUTION Advanced Medical Optics, Inc. | LPN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2008 | Advanced Medical Optics, Inc. AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, Lot Number: UD30654, 30 mg/mL fill size Terminated |
LZP | None listed |
| Aug 25, 2008 | Advanced Medical Optics, Inc. Opthalmic microsurgical system-AMO WHITESTAR SIGNATURE Phacoemulsification System, Product Number NGP680300. The device is a modular ophthalmic microsurgical system that facilitates both anterior se Terminated |
HQC | K060366 |
| Jul 19, 2007 | Advanced Medical Optics, Inc. COMPLETE Amino Moist Multi-Purpose Solution (JAPAN only brand), Formula 9451X, Product Numbers:93323JA, 93324JA, 93325JA, 93326JA, 93327JA, 93328JA, 93329JA, 93330JA, 93331JA, 93332JA, 93333JA, 93334J Terminated |
LPN | None listed |
| Jul 19, 2007 | Advanced Medical Optics, Inc. COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION, Formula 9451X;
(A) Fourteen US Product Numbers distributed under the COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION brand include: 90104 (MoisturePLUS, 12 o Terminated |
LPN | None listed |
| Mar 1, 2007 | Advanced Medical Optics, Inc. Lens Plus Ocupure Saline Sterile Rinsing Solution (Asia Pacific markets, excluding Japan) & Consept Rinsing Solution
(Japan only) Terminated |
LPN | None listed |
| Mar 1, 2007 | Advanced Medical Optics, Inc. Complete Blink N Clean (US and Asia Pacific markets) Terminated |
LPN | None listed |
| Mar 1, 2007 | Advanced Medical Optics, Inc. COMPLETE Multi-Purpose Solution (Asia Pacific markets, excluding Japan, Korea and Thailand), COMPLETE 10 Minute
(Japan only), Comfort 8 in 1 Solution (Indonesia only),
COMPLETE Comfort Plus All in Terminated |
LPN | K981168 |
| Mar 1, 2007 | Advanced Medical Optics, Inc. Krystal Klear Rinse (China only) Terminated |
LPN | K014202 |
| Mar 1, 2007 | Advanced Medical Optics, Inc. COMPLETE MoisturePLUS Multi-Purpose Solution
(US and Asia Pacific markets, excluding Japan) & COMPLETE Amino Moist Multi-Purpose Solution
(Japan only) Terminated |
LPN | None listed |
| Dec 14, 2006 | Advanced Medical Optics, Inc. AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses Terminated |
HQL | None listed |
| Dec 14, 2006 | Advanced Medical Optics, Inc. AMO PhacoFlex Il Model SI40NB Intraocular Lenses Terminated |
HQL | None listed |
| Oct 28, 2005 | Advanced Medical Optics, Inc. CeeOn Heparin SurfaceModifie (HSM) PMMA
One-Piece Anterior Chamber IOLs (Model: HSM65) Terminated |
HQL | None listed |
| Oct 28, 2005 | Advanced Medical Optics, Inc. CeeOn Heparin Surface
Modified (HSM) PMMA One-Piebe Posterior Chambet- IOLs (Models:722C, 722Y, 811C, 812C and 812CU) Terminated |
HQL | None listed |
| Oct 28, 2005 | Advanced Medical Optics, Inc. CeeOn EDGE Silicone
Posterior Chamber IOLs
(Modelsl 911A and 913A) Terminated |
HQL | None listed |
| Oct 28, 2005 | Advanced Medical Optics, Inc. Tecnis Multifocal Silicone Posterior Chamber IOLs (Model: ZM900) Terminated |
HQL | None listed |
| Oct 28, 2005 | Advanced Medical Optics, Inc. Tecnis Monofocal Silicone Posterior Chamber IOLs (Models: Z9000 and Z9001) Terminated |
HQL | None listed |
| Jul 13, 2005 | Advanced Medical Optics, Inc. CLARIS Cleaning and Soaking Solution, 4 fl. oz. Terminated |
LPN | None listed |