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510(k) Data Aggregation
K Number
K081681Device Name
VITRECTOMY CUTTER AND ACCESSORIES
Manufacturer
ADVANCED MEDICAL OPTICS, INC.
Date Cleared
2008-10-08
(113 days)
Product Code
MLZ
Regulation Number
886.4150Why 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.
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K Number
K081545Device 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
886.4300Why 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.
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K Number
K060366Device Name
THE AMO OPHTHALMIC SURGICAL SYSTEM
Manufacturer
ADVANCED MEDICAL OPTICS, INC.
Date Cleared
2006-04-07
(53 days)
Product Code
HQC
Regulation Number
886.4670Why 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.
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K Number
K042562Device Name
LENS PLUS REWETTING DROPS
Manufacturer
ADVANCED MEDICAL OPTICS, INC.
Date Cleared
2005-07-29
(311 days)
Product Code
LPN
Regulation Number
886.5928Why 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).
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K Number
K050648Device 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
886.4670Why 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.
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K Number
K040839Device Name
COMPLETE BLINK-N-CLEAN LENS DROPS
Manufacturer
ADVANCED MEDICAL OPTICS, INC.
Date Cleared
2004-10-19
(202 days)
Product Code
MRC
Regulation Number
886.5918Why 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.
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K Number
K032030Device Name
BLINK CL LUBRICANT EYE DROPS
Manufacturer
ADVANCED MEDICAL OPTICS, INC.
Date Cleared
2003-09-25
(86 days)
Product Code
LPN
Regulation Number
886.5928Why 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.
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K Number
K030092Device Name
COMPLETE BRAND MULTI-PURPOSE SOLUTION
Manufacturer
ADVANCED MEDICAL OPTICS, INC.
Date Cleared
2003-04-04
(84 days)
Product Code
LPN
Regulation Number
886.5928Why 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.
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