BEUDAMED
    FDA Enforcement Class I Terminated

    Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.

    Recall: Z-0865-2019 · Reported March 13, 2019

    Enforcement

    Recall Number
    Z-0865-2019
    Event ID
    81812
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    RVO 2.0, INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 13, 2019
    Initiation Date
    November 13, 2018
    Classification Date
    March 5, 2019
    Termination Date
    March 14, 2024
    Address
    26800 Aliso Viejo Pkwy, Ste 160, Aliso Viejo, CA, 92656-2625, United States

    Description

    Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.

    Reason

    During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.

    Code Info

    All lots of unused product

    Distribution

    U.S.: NV, GA, NY, MN, TX, ND, AZ, VA, SD, IN, MA, MO, CA, NC, UT, IL, NH, OH, OK, FL, NJ, TN, MI, PA, HI, ID, KY, NE, AL, LA, CO, MD, MS, OR, WI, AR, WA; No OUS (Foreign) Distribution.

    Quantity

    2869