BEUDAMED
    FDA Recall Terminated

    Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.

    Recall: Z-2366-2019 · Initiated July 11, 2016

    Recall

    Recall Number
    Z-2366-2019
    Event Number
    74671
    Firm
    Bausch & Lomb Inc Irb
    FEI Number
    1317628
    Product Code
    HNN
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    July 11, 2016
    Terminated
    August 30, 2019
    Address
    1400 N Goodman St, Rochester, NY, 14609-3547

    Description

    Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.

    Reason

    Possible dull knife edge

    Action

    On July 14, 2016, Baush + Lomb issued Medical Device Voluntary Product Recall notices to customers. Customers were instructed to take the following actions: 1. Please review your inventory and hold all unused boxes 2. Quarantine any unused boxes (full and partial) and take the following steps to return the product to Bausch + Lomb at the recalling firm's expense. 3. Please complete the Recall Acknowledgement Form and contact Bausch + Lomb to obtain a Return Material Authorization Number (RMA) and arrange for a pickup of the identified product. You can contact the Bausch + Lomb Surgical Customer Service team by calling 1-800-338-2020, Customer Service (option 2), Product Returns and Adverse Event Reporting (option 2).

    Distribution

    US Nationwide Distribution

    Quantity

    165 packs/6 blades (990 individiual blades)