BEUDAMED
    FDA Recall Terminated

    iSert Intraocular Lens (Model PC-60AD)

    Recall: Z-2802-2011 · Initiated June 17, 2011

    Recall

    Recall Number
    Z-2802-2011
    Event Number
    59207
    Firm
    Hoya Surgical Optics, Inc.
    FEI Number
    3006723646
    Product Code
    HQL
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    June 17, 2011
    Posted
    July 14, 2011
    Terminated
    November 29, 2012
    Address
    14768 Pipeline Ave, Chino Hills, CA, 91709-3594

    Description

    iSert Intraocular Lens (Model PC-60AD)

    Reason

    The recall was initiated because Hoya Surgical Optics has confirmed that the iSymm Intraocular Lens (Model FC-60AD) and iSert Intraocular Lens (Model PC-60AD) have been sold and marketed with out an FDA approval.

    Action

    Hoya Surgical Optics Inc. sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated June 22, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken. The letter instructs customers to quarantine affected product and return to HSO at their earliest convenience. Shipping instructions are included in the letter. Customers are to complete an Effectiveness Check Questionnaire and fax it to 1-909-680-3986. Questions regarding the recall process are directed to Hoya Customer Service at 1-866-750-5870 or e-mail at [email protected].

    Distribution

    Nationwide Distribution

    Quantity

    33,743 units total