BEUDAMED
    FDA Recall Open, Classified

    Legion FMS Pak

    Recall: Z-2409-2023 · Initiated June 28, 2023

    Recall

    Recall Number
    Z-2409-2023
    Event Number
    92698
    Firm
    Alcon Research, LTD.
    FEI Number
    2523835
    Product Code
    HQC
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 28, 2023
    Posted
    August 16, 2023
    Address
    714 Columbia Ave, Sinking Spring, PA, 19608-1405

    Description

    Legion FMS Pak

    Reason

    Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

    Action

    Customers were sent a Voluntary Medical Device Correction Notification by mail and dated 06/29/2023. Customers are asked to follow the risk mitigation precautions detailed in the notice to avoid the instance of overtightening the Phaco Tip and generating plastic particles. Additionally, customers are asked to forward the recall notification to all departments or organizations that use recalled devices. Customers are asked to complete and return the provided Response Form by fax at 817-302-4337 or email at [email protected]. Customers who have experienced any adverse events or quality related issues are to contact alcon via email at [email protected] or by phone at 1-800-757-9780, Option 5.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Aland Islands, Albania, Algeria, Andorran, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bermuda, Botswana, Brazil, Brunei Daruss., Bulgaria, Burma, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, French Guayana, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Isle of Man, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Montenegro, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Fed., Saint Martin, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, USA, USVI, Utd. Arab Emir., Uzbekistan, Vietnam, and Yemen.

    Quantity

    2,628 units