BEUDAMED
    FDA Enforcement Class II Terminated

    Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.

    Recall: Z-2365-2019 · Reported September 4, 2019

    Enforcement

    Recall Number
    Z-2365-2019
    Event ID
    74671
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bausch & Lomb Inc Irb
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2019
    Initiation Date
    July 11, 2016
    Classification Date
    August 23, 2019
    Termination Date
    August 30, 2019
    Address
    1400 N Goodman St, N/A, Rochester, NY, 14609-3547, United States

    Description

    Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.

    Reason

    Possible dull knife edge

    Code Info

    Lot Numbers: MAWS530 MAXA950 Expiry Dates: 01-2021

    Distribution

    US Nationwide Distribution

    Quantity

    384 packs/6 blades (2,304 individual blades)