BEUDAMED
    FDA Recall Terminated

    Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console.

    Recall: Z-1940-2015 · Initiated June 2, 2015

    Recall

    Recall Number
    Z-1940-2015
    Event Number
    71383
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    HQC
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    June 2, 2015
    Posted
    June 29, 2015
    Terminated
    April 20, 2017
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console.

    Reason

    Insufficient seal on the outside packaging, potentially affecting the sterility of the product.

    Action

    Recall notification letters were sent to consignees on June 2, 2015.

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Hong Kong, Hungary, India, International APL, Italy, Japan, Kenya, Korea, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Poland, Russia, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.

    Quantity

    35,475 units