Advanced Medical Optics, Inc.
Milpitas, CA, US
Advanced Medical Optics, Inc. appears in FDA device records in Milpitas, CA. FDA records list 38 510(k) clearances between and , 1,225 PMA records and 2 registered establishments. As of , FDA records show 87 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
5 namesFDA records resolved to Advanced Medical Optics, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Abbott Medical Optics Inc. (AMO)enforcement report, recall
- Abbott Medical Optics, Inc.510(k), PMA, enforcement report, recall
- Allergan Medical Optics510(k), recall
- AMO Manufacturing USA, LLCregistration, 510(k), PMA, enforcement report, recall
- Johnson & Johnson Surgical Vision, Inc.registration, 510(k), PMA, enforcement report, recall
510(k) clearance history
FDA records hold 38 510(k) clearances for Advanced Medical Optics, Inc. between 1989 and 2023. The busiest year on record is 2011, with 4. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 1 |
| 2008 | 2 |
| 2010 | 1 |
| 2011 | 4 |
| 2012 | 2 |
| 2014 | 1 |
| 2015 | 4 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 2 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223566 | ELITA™ Femtosecond Laser System, ELITA™ Patient Interface | OOE | Substantially Equivalent | |
| K223838 | Catalys™ Precision Laser System | OOE | Substantially Equivalent | |
| K220516 | CATALYS Precision Laser system | OOE | Substantially Equivalent | |
| K210701 | CATALYS Precision Laser System | OOE | Substantially Equivalent | |
| K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control | HQC | Substantially Equivalent | |
| K191949 | UNFOLDER Vitan Inserter | MSS | Substantially Equivalent | |
| K191933 | COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal | HQC | Substantially Equivalent | |
| K182083 | Catalys Precision Laser System | OOE | Substantially Equivalent | |
| K172002 | Catalys Precision Laser System | OOE | Substantially Equivalent | |
| K170322 | Catalys Precision Laser System | OOE | Substantially Equivalent | |
| K160236 | Dual Pump Pack | HQC | Substantially Equivalent | |
| K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control | HQC | Substantially Equivalent | |
| K151783 | COMPACT INTUITIV Multiple-Use Pack | HQC | Substantially Equivalent | |
| K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | MSS | Substantially Equivalent | |
| K141852 | IFS ADVANCED FEMTOSECOND LASER SYSTEM | GEX | Substantially Equivalent | |
| K133115 | COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK | HQC | Substantially Equivalent | |
| K121721 | LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) | HQC | Substantially Equivalent | |
| K113151 | IFS LASER SYSTEM | GEX | Substantially Equivalent | |
| K111446 | SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM | HQC | Substantially Equivalent | |
| K111882 | LAMINAR FLOW PHACO TIPS | HQC | Substantially Equivalent | |
| K111697 | AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM | HQC | Substantially Equivalent | |
| K103023 | UNIT, PHACOFRAGMENTATION | HQC | Substantially Equivalent | |
| K093254 | AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION | LPN | Substantially Equivalent | |
| K081681 | VITRECTOMY CUTTER AND ACCESSORIES | MLZ | Substantially Equivalent | |
| K081545 | ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 | MSS | Substantially Equivalent | |
| K060366 | THE AMO OPHTHALMIC SURGICAL SYSTEM | HQC | Substantially Equivalent | |
| K042562 | LENS PLUS REWETTING DROPS | LPN | Substantially Equivalent | |
| K050648 | SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK | HQC | Substantially Equivalent | |
| K040839 | COMPLETE BLINK-N-CLEAN LENS DROPS | MRC | Substantially Equivalent | |
| K032030 | BLINK CL LUBRICANT EYE DROPS | LPN | Substantially Equivalent | |
| K030092 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | LPN | Substantially Equivalent | |
| K951462 | AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM | HQC | Substantially Equivalent | |
| K941603 | AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE | KYB | Substantially Equivalent | |
| K930320 | AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR | KYB | Substantially Equivalent | |
| K925254 | AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 | HQC | Substantially Equivalent | |
| K924235 | AMO ELITE | HQC | Substantially Equivalent | |
| K911998 | MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM | HQE | Substantially Equivalent | |
| K893199 | PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR | HNR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006695864 | 3006695864 | AMO Manufacturing USA, LLC | 510 Cottonwood Drive, Milpitas, CA 95035 US | 2026 | |
| 3012236936 | 3012236936 | Johnson & Johnson Surgical Vision, Inc. | 31 Technology Drive, Irvine, CA 92618 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LPNAccessories, Soft Lens Products
- LZPAid, Surgical, Viscoelastic
- HMXCannula, Ophthalmic
- KYGDevice, Irrigation, Ocular Surgery
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- LZSExcimer Laser System
- POEExtended Depth Of Focus Intraocular Lens
- MSSFolders And Injectors, Intraocular Lens (Iol)
- HNRForceps, Ophthalmic
- KYFImplant, Eye Valve
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
- HKPInstrument, Vitreous Aspiration And Cutting, Battery-Powered
- HQLIntraocular Lens
- HNOKeratome, Ac-Powered
- HQDLens, Contact (Other Material) - Daily
- KYBLens, Guide, Intraocular
- MJPLens, Intraocular, Toric Optics
- MFKLens, Multifocal Intraocular
- LPMLenses, Soft Contact, Extended Wear
- OOEOphthalmic Femtosecond Laser
- GEXPowered Laser Surgical Instrument
- MRCProducts, Contact Lens Care, Rigid Gas Permeable
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- HRDSterilizer, Soft-Lens, Thermal, Ac-Powered
- HQCUnit, Phacofragmentation
- MLZVitrectomy, Instrument Cutter
Recall records
Showing 25 of 87| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3064-2026 | HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET PRO II, REF: 10301016 (EU) | Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment. | Class II | Open, Classified | |
| Z-1755-2024 | Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery. | Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause possible harms. | Class II | Open, Classified | |
| Z-0735-2024 | TECNIS Toric II OptiBlue IOL Models ZCW | Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks. | Class II | Open, Classified | |
| Z-2289-2023 | TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only | Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks. | Class II | Open, Classified | |
| Z-2288-2023 | TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only | Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks. | Class II | Open, Classified | |
| Z-2247-2023 | VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF) | Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema. | Class II | Open, Classified | |
| Z-1007-2023 | Single-Use Packs, REF: OPO80 | Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema. | Class II | Open, Classified | |
| Z-1006-2023 | FUSION Dual Pump Packs, REF: OPO73 | Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema. | Class II | Open, Classified | |
| Z-1005-2023 | Veritas Advanced Infusion Packs, REF: VRT-AI | Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema. | Class II | Open, Classified | |
| Z-0169-2023 | THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation. | Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect. | Class II | Open, Classified | |
| Z-0086-2023 | Veritas Advanced Infusion Packs. Used in ophthalmic procedures. | As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue. | Class II | Open, Classified | |
| Z-1033-2022 | TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only, | Potential breach in the sterility barrier for tray ring covers. | Class II | Open, Classified | |
| Z-0444-2022 | Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed, Models: 0160-6020 (United States), 0160-6010 (International) | Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation of new accounts with full user rights. | Class II | Open, Classified | |
| Z-0443-2022 | iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301 | Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation of new accounts with full user rights. | Class II | Open, Classified | |
| Z-0028-2022 | 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. | Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance. | Class II | Terminated | |
| Z-1163-2021 | TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag. | Due to the release of nonconforming Intraocular Lenses (IOLs). | Class II | Terminated | |
| Z-0867-2020 | Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14 | Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative intraocular pressure requiring additional intervention. Also, reports of clogging of phacoemulsion equipment tubing, which may lead to delay in the procedure or ocular injury. | Class II | Terminated | |
| Z-1893-2019 | Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from the eye. It has been designed as a disposable (single use) | Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement. | Class II | Terminated | |
| Z-0464-2019 | Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag. | Expired intraocular lenses were distributed. | Class II | Terminated | |
| Z-0066-2019 | OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. | Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment overlay screen on the system GUI. | Class II | Terminated | |
| Z-2067-2017 | Healon V, Part No. 10290045 | Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. | Class II | Terminated | |
| Z-2066-2017 | Healon Pro, Part No. 10270012 | Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. | Class II | Terminated | |
| Z-2065-2017 | Healon 5 Pro, Part No. 10270015 | Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. | Class II | Terminated | |
| Z-2064-2017 | Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012 | Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. | Class II | Terminated | |
| Z-2063-2017 | Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014 | Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain