Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K081681
    Device Name
    VITRECTOMY CUTTER AND ACCESSORIES
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Date Cleared
    2008-10-08

    (113 days)

    Product Code
    MLZ
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED MEDICAL OPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. These devices are for use with the Whitestar Signature™ System.
    Device Description
    The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. The vittectomy mode is used to cut and remove vitreous matter from the anterior segment of the eye during secondary intraocular lens implantation following vitreous loss associated with trauma or during primary cataract surgery. It can also be used to provide vitreous cutting in the posterior segment by enabling surgeons to remove vitreous matter for the treatment of various posterior segment conditions.
    Ask a Question
    K Number
    K081545
    Device Name
    ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Date Cleared
    2008-10-02

    (122 days)

    Product Code
    MSS, KYB
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED MEDICAL OPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used to fold and assist in inserting TECNIS® 1-Piece intraocular lenses into the eye.
    Device Description
    The One Series™ Ultra cartridge is used to fold and assist in the insertion of a TECNIS® 1-Piece soft acrylic intraocular lens (IOL) into the eye following cataract extraction. The cartridge, Model 1VIPR30 is a single-use component composed of polypropylene which is injection molded and coated with a lubricious coating. The cartridge is provided sterile. The IOL is loaded into the proximal portion of the cartridge using forceps. The cartridge is then placed in a reusable titanium handpiece, which advances the IOL through the tube section of the cartridge and delivers it into the eye.
    Ask a Question
    K Number
    K060366
    Device Name
    THE AMO OPHTHALMIC SURGICAL SYSTEM
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Date Cleared
    2006-04-07

    (53 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED MEDICAL OPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMO Ophthalmic Surgical System is a modular ophthalmic microsurgical system that facilitates both anterior segment (i.e., cataract) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The posterior segment surgery module is optional. The modular design allows the users to configure the system to meet their surgical requirements.
    Device Description
    The AMO Ophthalmic Surgical System is a device designed for use in performing anterior segment ophthalmic surgery (cataract) and posterior segment ophthalmic surgery. The device is intended for use in performing phacoemulsification, phacofragmentation, diathermy, irrigation/aspiration, vitrectomy, extrusion and silicone oil injection and extraction.
    Ask a Question
    K Number
    K042562
    Device Name
    LENS PLUS REWETTING DROPS
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Date Cleared
    2005-07-29

    (311 days)

    Product Code
    LPN
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED MEDICAL OPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use LENS PLUS® Rewetting Drops while wearing your lenses to moisten and rehydrate them. Also, use LENS PLUS® Rewetting Drops to relieve minor irritation, discomfort and/or blurring which may occur while wearing your lenses.
    Device Description
    Lens Plus® Rewetting Drops is a sterile, preservative free, buffered, isotonic, aqueous solution containing sodium chloride and boric acid. The product is packaged in a plastic sterile reclosable vial which allows remaining drops can be used throughout the day (12 hours).
    Ask a Question
    K Number
    K050648
    Device Name
    SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Date Cleared
    2005-04-05

    (22 days)

    Product Code
    HQC, HOC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED MEDICAL OPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOVEREIGN® High Vacuum Pack is indicated for use with the SOVEREIGN® phacoemulsification machine. The SOVEREIGN® High Vacuum pack includes a filter protected flow restriction orifice used during cataract surgery to minimize vacuum surges in the aspiration line. The SOVEREIGN® Compact High Vacuum Pack is indicated for use with the SOVEREIGN® Compact phacoemulsification machine. The SOVEREIGN® Compact High Vacuum pack includes a filter protected flow restriction orifice used during cataract surgery to minimize vacuum surges in the aspiration line.
    Device Description
    The SOVEREIGN® High Vacuum Pack and the SOVEREIGN® Compact High Vacuum Pack are accessory kits indicated for use with the SOVEREIGN® phacoemulsification machine and the SOVEREIGN® Compact phacoemulsification machine, respectively, to perform an irrigation/aspiration (I/A) procedure or a phacoemulsification procedure during cataract surgery. The tubing assembly component of the kit incorporates a flow restriction feature for preventing/neutralizing post occlusion surge following an occlusion break at the distal end of a phaco tip. The materials, basic scientific concepts, physical properties and intended use of the device kits are similar to those of the identified predicate devices.
    Ask a Question
    K Number
    K040839
    Device Name
    COMPLETE BLINK-N-CLEAN LENS DROPS
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Date Cleared
    2004-10-19

    (202 days)

    Product Code
    MRC
    Regulation Number
    886.5918
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED MEDICAL OPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    COMPLETE® BLINK-N-CLEAN® Lens Drops is indicated to lubricate and rewet soft (hydrophilic) contact lenses, disposable lenses and extended wear lenses, as well as rigid gas permeable lenses before application and during wear.
    Device Description
    COMPLETE® BLINK-N-CLEAN® Lens Drops is a sterile, isotonic, buffered, solution containing lubricants, preservatives, buffers, surfactants, ancillary ingredients, and purified water. The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
    Ask a Question
    K Number
    K032030
    Device Name
    BLINK CL LUBRICANT EYE DROPS
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Date Cleared
    2003-09-25

    (86 days)

    Product Code
    LPN
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED MEDICAL OPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use blink™ CL Lubricant Eye Drops to lubricate and rewet soft and rigid gas permeable (RGP) contact lenses; to help relieve dryness, irritation and discomfort that may be associated with lens wear; and to cushion lenses by placing a drop on the lens prior to application on the eye.
    Device Description
    blink™ CL Lubricant Eye Drops is a sterile, isotonic, buffered solution containing a lubricant, a preservative, buffers, tonicity agents, and purified water. The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
    Ask a Question
    K Number
    K030092
    Device Name
    COMPLETE BRAND MULTI-PURPOSE SOLUTION
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Date Cleared
    2003-04-04

    (84 days)

    Product Code
    LPN
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED MEDICAL OPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    COMPLETE® brand Multi-Purpose Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to: - Chemically (NOT HEAT) Disinfect . - Clean ● - Rinse . - Store - Remove Protein . - Condition .
    Device Description
    COMPLETE® brand MULTI-PURPOSE Solution is a sterile, isotonic, buffered, solution containing hydroxypropyl methylcellulose as a lubricant, preserved with polyhexamethylene biguanide 0.0001%, a phosphate buffer, Poloxamer 237 as a surfactant, edetate disodium as a chelating agent, sodium chloride, potassium chloride, and purified water. COMPLETE® brand MULTI-PURPOSE Solution contains no chlorhexidine or thimerosal. The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
    Ask a Question

    Page 1 of 1