Events

Recall of Device Recall Raindrop Near Vision Inlay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Revision Optics Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76422
  • Event Risk Class
    Class 2
  • Event Number
    Z-1518-2017
  • Event Initiated Date
    2017-02-07
  • Event Date Posted
    2017-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153166
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implant, corneal, refractive - Product Code LQE
  • 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.

Device

Device Recall Raindrop Near Vision Inlay
  • Model / Serial
    multiple lots since 08/01/2016
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • 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
  • Product Description
    Raindrop Near Vision Inlay, Model# RD1-1
  • Manufacturer
    Revision Optics Inc

Manufacturer

Revision Optics Inc
  • Manufacturer Address
    Revision Optics Inc, 25651 Atlantic Ocean Dr Ste A1, Lake Forest CA 92630-8835
  • Manufacturer Parent Company (2017)
    ReVision Optics Inc.
  • Source
    USFDA