BEUDAMED
    Product Code: NIZ FDA class 3 21 CFR 886.3600

    Lens, Iris Reconstruction

    Ophthalmic

    The Iris Reconstruction Lens is an intraocular lens (IOL) used in patients with partial or complete loss of the iris due to trauma or congenital defect, serving as both an artificial iris and lens to reduce light sensitivity and/or glare disability, and implanted in the capsular bag or sulcus for correction of aphakia and aniridia. It is classified as FDA Class 3 (Premarket Approval), requiring PMA approval, under product code NIZ and regulation 21 CFR 886.3600 in the Ophthalmic specialty. The device is flagged as an implant and is not life-sustaining.

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    510(k)s
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    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    NIZ
    Device Class
    FDA class 3
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting

    Definition

    An iris reconstruction lens is an intraocular lens (IOL) which is used in patients with partial or complete loss of the iris induced by trauma or congenital defect. The IOL serves as an artificial iris and lens, reducing light sensitivity and/or glare disability. The device is implanted in the capsular bag or sulcus for the correction of aphakia and aniridia.