BEUDAMED
    FDA Enforcement Class II Terminated

    SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

    Recall: Z-2855-2016 · Reported September 28, 2016

    Enforcement

    Recall Number
    Z-2855-2016
    Event ID
    75051
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Medical Optics Inc. (AMO)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 28, 2016
    Initiation Date
    August 26, 2016
    Classification Date
    September 21, 2016
    Termination Date
    December 23, 2016
    Address
    1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933, United States

    Description

    SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

    Reason

    Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.

    Code Info

    Serial No. 5626941507 5626961507 5626981507 5627001507 2003061505 2004131506 2015871503 3848581509 5626621507 5626641507 5626651507 5626661507 5626671507 5626681507 5626691507 5626701507 5626711507 5626721507 5626731507 5626741507 5626751507 5626761507 5626771507 5626791507 5626801507 5626811507 5626821507 5626831507 5626841507 5626851507 5626861507 5626871507 5626881507 5626891507 5626901507 5626911507 5626921507 5626931507 5626951507 5626971507 5627011507 5627021507 5627031507 5627041507 5627051507 5627061507 5627071507 5627081507 5627091507 5627101507 5627111507 5627121507 5627131507 5627141507 5627151507 5627161507 5627171507 5627181507 5627191507 5627201507 5627211507 5627221507

    Distribution

    Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.

    Quantity

    84 units