BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P880087 · Supplement: S010 · Decision Apr 29, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    ACRYSOF UV-ABSORBING PMMA SINGLE-PIECE ANTERIOR CHAMBER
    PMA Number
    P880087
    Supplement Number
    S010
    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
    April 29, 2004
    Date Received
    April 16, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE INDICATIONS STATEMENT, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS FOLLOWING CATARACT SURGERY. PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER WHEN EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICATION ARE PERFORMED OR WHERE A CATARACTOUS LENS HAS BEEN REMOVED. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULTS FOLLOWING CATARACT SURGERY.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens