BEUDAMED
    FDA Recall Terminated

    Tecnis Monofocal Silicone Posterior Chamber IOLs (Models: Z9000 and Z9001)

    Recall: Z-0093-06 · Initiated October 5, 2005

    Recall

    Recall Number
    Z-0093-06
    Event Number
    33849
    Firm
    Advanced Medical Optics, Inc.
    FEI Number
    3003843509
    Product Code
    HQL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 5, 2005
    Posted
    October 28, 2005
    Terminated
    May 23, 2008
    Address
    1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933

    Description

    Tecnis Monofocal Silicone Posterior Chamber IOLs (Models: Z9000 and Z9001)

    Reason

    A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.

    Action

    A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.

    Distribution

    Nationwide, Austria, Belgium, Switzerland, Germany, Denmark, France, UK, Guadelope, Hong Kong, Croatia, India, Italy, Netherlands, and Vietnam

    Quantity

    107 (39 in US)