BEUDAMED
    FDA Recall Terminated

    Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.

    Recall: Z-2154-2015 · Initiated May 26, 2015

    Recall

    Recall Number
    Z-2154-2015
    Event Number
    71411
    Firm
    Bausch & Lomb Surgical, Inc.
    FEI Number
    1119279
    Product Code
    HQL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 26, 2015
    Posted
    July 20, 2015
    Terminated
    August 25, 2016
    Address
    21 N Park Place Blvd, Clearwater, FL, 33759-3917

    Description

    Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.

    Reason

    Haptics breaking during lens loading and insertion.

    Action

    Bausch + Lomb sent an Urgent Medical Device Recall letter dated May 29, 2015 to their custometers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: segregate the identified IOLs, return the IOLs through your B&L representative or by using the prepaid shipping label included in this package, order replacement product through customer service (800) 338-2020 or your B&L representative and complete & return the acknowledgement form included in this package. Customers were advised that if replacement product is needed for a scheduled surgery before your full return can be processed, please contact your B&L representative to expedite shipment of the IOL. For questions contact Bausch + Lomb at (800) 338-2020.

    Distribution

    Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MD, MN, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, Hawaii and Puerto Rico and countries of: Canada, Brazil, Argentina, Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Georgia, Greece, Kyrgyzstan, Norway, Russia, Ukraine, United Arab Emirates, China, Australia, India Malaysia, Korea, and Taiwan.

    Quantity

    72,773 units; 52,787 units (US) 19,986 units (Foreign)