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510(k) Data Aggregation

    K Number
    K161012
    Device Name
    Easy-Load Lens Delivery System
    Manufacturer
    Bausch and Lomb, Inc.
    Date Cleared
    2016-07-06

    (86 days)

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

    Bausch and Lomb, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Easy-Load Lens Delivery System is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the Easy-Load Lens Delivery System in their approved labeling.
    Device Description
    The Easy-Load Lens Delivery System is used for folding and delivering a Bausch + Lomb three-piece silicone IOL into the eye. An IOL is placed into the loading area and the drawer is closed. This compresses the IOL. The plunger is advanced until it stops at a detent position. The distal end is filled with viscoelastic or balanced salt solution and placed through an incision into the eye. The haptic puller is used to place the leading haptic in the correct loading position. Once the tip is in the eye, the plunger is advanced until the lens is fully expressed into the capsular bag.
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