BEUDAMED
    FDA Recall Terminated

    Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.

    Recall: Z-0961-2019 · Initiated July 17, 2018

    Recall

    Recall Number
    Z-0961-2019
    Event Number
    82024
    Firm
    Alcon Research Laboratories Ltd. Aspex Facility
    FEI Number
    1610287
    Product Code
    HRM
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 17, 2018
    Posted
    February 27, 2019
    Terminated
    April 28, 2021
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.

    Reason

    Potential for the optical head to detach from the stand due to the lack of thread adhesive.

    Action

    On July 17, 2018 the firm sent letters to their consignees with the following instructions: To assist us in this Voluntary Medical Device Correction, please take the following steps: 1. Inspect your microscope prior to continued use per the instruction above. 2. If either the Functional or Visual tests have failed, stop use of the device immediately and notify Alcon at 1-800-832-7827. 3. Forward this information immediately to all departments within your organization who may be using the Alcon or Endure LuxOR E71 Ophthalmic Microscope and Alcon or Endure LuxOR E71 Q-Vue Ophthalmic Microscope. 4. If applicable, provide a copy of this notification to any other organization I location to which the Alcon or Endure LuxOR E71 Ophthalmic Microscope and Alcon or Endure LuxOR E71 Q-Vue Ophthalmic Microscope has been sold or moved. 5. Return the attached Response Form via fax or email to Alcon.

    Distribution

    Worldwide Distribution - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, Ml, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and US Virgins Islands Australia, Austria, Bahamas, Belarus, Canada, Chile, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, Germany, Guatemala, India, Indonesia, Italy, Jamaica, Japan, Kenya, Lebanon, Mexico, Netherland Antilles, Norway, Peru, Philippines, Poland, Romania, Slovakia, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, and Vietnam

    Quantity

    544 (399 units to USA)