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510(k) Data Aggregation
K Number
K191650Device Name
LEGION System
Manufacturer
Date Cleared
2019-11-01
(134 days)
Product Code
Regulation Number
886.4670Why did this record match?
Applicant Name (Manufacturer) :
Alcon Research, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Legion™ System is indicated for emulsification, separation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The AutoSert™ IOL Injector Handpiece is intended to deliver qualified AcrySof™ intraocular lenses into the eye following cataract removal.
The AutoSert™ IOL Injector Handpiece achieves the function of intraocular lenses. The AutoSert™ IOL Injector Handpiece is indicated for use with AcrySof™ lenses SN60WF, SN6AT3 through SN6AT9, as well as approved AcrySof™ lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
Device Description
The LEGION™ System is intended for use in anterior segment ophthalmic surgery procedures that require simultaneous lens extraction via phacoemulsification, irrigation and aspiration, and associated procedures such as anterior vitrectomy, coagulation and intraocular lens (IOL) insertion.
The LEGION™ System consists of a standalone tabletop console, which performs the core functionalities for cataract lens extraction. The LEGION™ System's console provides two electrical connector ports that support the CENTURION™ series of ultrasound handpieces, an electric vitrectorny cutter, the Alcon AutoSert™ IOL Injector and a Coagulation accessory port on both sides of the Fluidics module. The OZIL torsional technology of Alcon's phacoemulsification handpieces and tips operates with ultrasonic torsional oscillations which can be used exclusively. combined or alternated with traditional longitudinal phacoemulsification. The traditional modalities of ultrasonic power control including continuous, pulsed, and burst application of ultrasonic power, as well as duty cycle management are available.
The same fluidics module and overall fluid management system (FMS) design of the predicate device (CENTURION™ Vision System) is used on the LEGION™ System. The FMS is an interface between the LEGION™ System Console (Fluidics Module) and the surgical handpieces, used to regulate irrigating fluid to the handpiece, aspirate fluid and debris from the handpiece, monitor irrigation and aspiration pressure and deposit the fluid and debris in a sealed drainage bag This single assembly contains a rigid plastic fluidic chamber, non-invasive pressure/vacuum sensor, drain bag, irrigating fluid administration line, as well as irrigation and aspiration handpiece tubing.
Two types of FMS can be used with the LEGION™ System: Single Use and MultiPak FMS. The MultiPak FMS is intended to be a day-use cassette for up to 12 consecutive procedures (patients). The primary difference between the single use and MultiPak FMS is the ability to replace the single use sterile irrigation (1/A) manifold and drain bag. Several design aspects have been implemented to reduce the risk of cross-contamination when using the MultiPak FMS.
The LEGION™ System utilizes gravity-based irrigation (i.e. irrigation pressure derived from the height of the irrigation fluid bag or bottle). The LEGION™ System can be used in conjunction with a manual IV pole, or can be used with the optional LEGION™ cart, which is equipped with a powered IV pole.
The LEGION™ System supports anterior vitrectomy procedures via compatibility with the reusable LEGION™ anterior vitrectomy handpiece and consumable vitrectomy probe. The reusable anterior vitrectomy handpiece drives the guillotine-style consumable vitrectomy probe to achieve anterior vitrectomy functionality.
The LEGION™ System provides bipolar coagulation capability via support for Alcon coagulation handpieces and tips, with a power rating identical to the predicate device.
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