BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P930014 · Decision Dec 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES
    PMA Number
    P930014
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 22, 1994
    Date Received
    May 28, 1993
    Expedited Review
    N
    Docket Number
    96M-0221

    Advisory Committee Statement

    Approval for the ACRYSOf® Models MA60BM and MA30BA Ultraviolet-Absorbing Acrylic Foldable UV-Absorbing Posterior Chamber Intraocular Lenses (IOLs). These devices are indicated for replacement of the human lens to achieve visual correction of aphakia in patients 60 years of age and older when extracapsular cataract extraction or phacoemulsification are performed. These lenses are intended for placement in the capsular bag.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQL Intraocular Lens