BEUDAMED
    FDA Enforcement Class II Terminated

    Raindrop Near Vision Inlay, Model# RD1-1

    Recall: Z-1518-2017 · Reported March 29, 2017

    Enforcement

    Recall Number
    Z-1518-2017
    Event ID
    76422
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Revision Optics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 29, 2017
    Initiation Date
    February 7, 2017
    Classification Date
    March 21, 2017
    Termination Date
    June 21, 2017
    Address
    25651 Atlantic Ocean Dr Ste A1, Lake Forest, CA, 92630-8835, United States

    Description

    Raindrop Near Vision Inlay, Model# RD1-1

    Reason

    ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to emphasize that only Balanced Salt Solution (BSS) may be used to irrigate under the flap and that topical medications or lubricants should not be administered until centration of the inlay and proper flap positioning has been confirmed at the slit lamp.

    Code Info

    multiple lots since 08/01/2016

    Distribution

    US: AL, AZ, CA, FL, GA, HI, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, SD, TN, TX, UT, WA

    Quantity

    1,279 devices