BEUDAMED
    FDA Recall Terminated

    23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.

    Recall: Z-1693-2016 · Initiated August 11, 2015

    Recall

    Recall Number
    Z-1693-2016
    Event Number
    73777
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    NGY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 11, 2015
    Posted
    May 18, 2016
    Terminated
    April 20, 2017
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.

    Reason

    The product has potential to leak beyond their design specification.

    Action

    The affected consignees were contacted via letter on 8/11/15 to communicate the potential for leakage.

    Distribution

    United States, Argentina, Armenia, Australia, Azerbaijan, Bangladesh, Brbados, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Curacao, Cypress, Denmark, Ecuador, Finland, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Lsreal, Italy, Japan, Korea, Lithuania, Malta, Mexico, Monaco, Netherlands, New Zealand, Pakistam, Philippines, Poland, Prtougal, Puerto Rico, Romania, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay

    Quantity

    225,000 units