BEUDAMED
    FDA Enforcement Class II Terminated

    BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).

    Recall: Z-1066-2019 · Reported April 3, 2019

    Enforcement

    Recall Number
    Z-1066-2019
    Event ID
    81757
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beaver Visitec
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2019
    Initiation Date
    November 30, 2018
    Classification Date
    March 27, 2019
    Termination Date
    May 1, 2020
    Address
    500 Totten Pond Rd, 10 City Point, Waltham, MA, 02451-1916, United States

    Description

    BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).

    Reason

    Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigate the possibility of injury.

    Code Info

    Lots 60047S4, 60060S9, 600623S

    Distribution

    Worldwide distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, GA, LA, MD, MO, NC, NE, NJ, NY, OH, OK, TX, UT, VA, WA; and countries of: Mexico and Peru.

    Quantity

    3430 units