BEUDAMED
    FDA Enforcement Class II Ongoing

    CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissue. Ref: CT00.D01

    Recall: Z-1497-2023 · Reported May 10, 2023

    Enforcement

    Recall Number
    Z-1497-2023
    Event ID
    91986
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beaver Visitec International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    May 10, 2023
    Initiation Date
    March 17, 2023
    Classification Date
    May 2, 2023
    Address
    500 Totten Pond Rd, 10 City Point, Waltham, MA, 02451-1916, United States

    Description

    CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissue. Ref: CT00.D01

    Reason

    Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenly or forcefully disassembles during a cryosurgery procedure.

    Code Info

    GTIN: 08719214223458 All Affected Lots: 20214450, 20214366, 20214367, 20214518, 20214522, 20214615, 20214744, 20214745, 20214961, 20214962, 20215203, 20215204, 20215479, 20216263, 20216264, 20216010, 20227952, 20227950, 20227951, 20228408, 20228657, 20228897, 20228898, 20229034, 20229138, 20229334, 20229460, 20229630, 20229748, 20230261, 20221083, 20221140, 20221364, 20221746, 20221894, 20222365

    Distribution

    US Nationwide distribution.

    Quantity

    501 (USA)