BEUDAMED
    FDA Recall Terminated

    Raindrop Near Vision Inlay, Model# RD1-1

    Recall: Z-1518-2017 · Initiated February 7, 2017

    Recall

    Recall Number
    Z-1518-2017
    Event Number
    76422
    Firm
    Revision Optics Inc
    FEI Number
    3005956347
    Product Code
    LQE
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    February 7, 2017
    Posted
    March 21, 2017
    Terminated
    June 21, 2017
    Address
    25651 Atlantic Ocean Dr, Ste A1, Lake Forest, CA, 92630-8835

    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.

    Action

    A Dear Doctor letter was sent to inform customers that ReVision Optics wanted to share a surgical update regarding the Raindrop Near Vision Inlay procedure. Customers are informed that no ophthalmic medications or lubricants should be used immediately prior to or during placement of the Raindrop Near Vision Inlay. Only Balanced Salt Solution (BSS) should be used to irrigate under the flap during the Raindrop procedure. Customers are informed that ophthalmic medications or lubricants should be administered only after verifying proper inlay centration and flap positioning as observed at the slit lamp. This ensures that no further inlay or flap manipulation is required. ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to emphasize that only 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. Customers with questions are instructed to contact Luis Vargas regarding the surgical procedure update.

    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