BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P110007 · Decision Jul 2, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)
    PMA Number
    P110007
    Device Class
    FDA Class 3
    Product Code
    LZP
    Generic Name
    AID, SURGICAL, VISCOELASTIC
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 2, 2012
    Date Received
    February 22, 2011
    Expedited Review
    N
    Docket Number
    12M-0734

    Advisory Committee Statement

    APPROVAL FOR THE HEALON ENDOCOAT OVD. HEALON ENDOCOAT OVD IS AN OPHTHALMIC VISCOELASTIC CONTAINING 3% SODIUM HYALURONATE INDICATED FOR USE AS A SURGICAL AID IN PATIENTS UNDERGOING OPHTHALMIC ANTERIOR SEGMENT SURGICAL PROCEDURES INCLUDING, CATARACT SURGERY WITH AN INTRAOCULAR LENS, CATARACT SURGERY WITHOUT AN INTRAOCULAR LENS, AND SECONDARY INTRAOCULAR LENS IMPLANTATION. HEALON ENDOCOAT OVD MAINTAINS A DEEP CHAMBER DURING ANTERIOR SEGMENT SURGERY, ENHANCES VISUALIZATION DURING THE SURGICAL PROCEDURE AND PROTECTS THE CORNEAL ENDOTHELIUM AND OTHER OCULAR TISSUE. THE VISCOELASTICITY OF THE SOLUTION MAINTAINS THE NORMAL POSITION OF THE VITREOUS FACE AND PREVENTS FORMATION OF A FLAT CHAMBER DURING SURGERY. IT MAY ALSO BE USED TO COAT INTRAOCULAR LENSES AND INSERTION INSTRUMENTS PRIOR TO INTRAOCULAR LENS IMPLANTATION.

    Classifications

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

    Product Code Device Name
    LZP Aid, Surgical, Viscoelastic