BEUDAMED
    FDA Enforcement Class II Terminated

    LASEREDGE Knives, 1.1MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7592, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

    Recall: Z-0888-2018 · Reported March 14, 2018

    Enforcement

    Recall Number
    Z-0888-2018
    Event ID
    76874
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bausch & Lomb Inc Irb
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 14, 2018
    Initiation Date
    March 3, 2017
    Classification Date
    March 5, 2018
    Termination Date
    June 25, 2018
    Address
    1400 Goodman St N, N/A, Rochester, NY, 14609-3547, United States

    Description

    LASEREDGE Knives, 1.1MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7592, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

    Reason

    The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.

    Code Info

    none

    Distribution

    US Nationwide Distribution

    Quantity

    1,236,749 knives in total