BEUDAMED
    FDA Recall Terminated

    VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of incisions in the cornea. The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This device is intended for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >=-1.00 D to <=-8.00 D, with <=-0.50 D cylinder and MRSE <=-8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <=0.50 D MRSE.

    Recall: Z-0680-2020 · Initiated December 6, 2018

    Recall

    Recall Number
    Z-0680-2020
    Event Number
    83913
    Firm
    Carl Zeiss Meditec, Inc.
    FEI Number
    2918630
    Product Code
    OTL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 6, 2018
    Terminated
    February 2, 2021
    Address
    5160 Hacienda Dr, Dublin, CA, 94568-7562

    Description

    VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of incisions in the cornea. The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This device is intended for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >=-1.00 D to <=-8.00 D, with <=-0.50 D cylinder and MRSE <=-8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <=0.50 D MRSE.

    Reason

    VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during treatment the software allows the user to choose the option immediate restart or restart treatment. Suction loss can occur in phase 1 through phase 5. The software defect refers to Phase 2 (between 10% and 100% of lower lenticule cut) only. The software offers a flap cut, but due to the software issue it performs a cap cut instead of a flap cut if the user proceeds.

    Action

    Consignees were notified with an Urgent Medical Device Recall letter dated 12/06/2019. The letter identified affected devices, described the software issue, and provided direction on what steps to take with suction loss in phase 2, until a software update is available. A response form was asked to be returned. Questions can be directed to 877-486-7473.

    Distribution

    US nationwide distribution.

    Quantity

    66 units