Events

Recall of VersaVit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synergetics 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
    74918
  • Event Risk Class
    Class 2
  • Event Number
    Z-0120-2017
  • Event Initiated Date
    2016-08-11
  • Event Date Posted
    2016-10-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148779
  • 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
    Instrument, vitreous aspiration and cutting, ac-powered - Product Code HQE
  • Reason
    Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
  • Action
    A customer notification letter was sent out on 8/11/2016 to the hospital/surgical center level. Customers were asked to fill out and return a recall acknowledgment form and send back any affected devices.

Device

VersaVit
  • Model / Serial
    Lot number M548370 (1 each or box of 6 each), exp 11/2018 Lot number M578150 (1 each or box of 6 each), exp 02/2019
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT. Foreign distribution to the UK, France, Mexico, and India.
  • Product Description
    25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
  • Manufacturer
    Synergetics Inc

Manufacturer

Synergetics Inc
  • Manufacturer Address
    Synergetics Inc, 3845 Corporate Centre Dr, O Fallon MO 63368-8678
  • Manufacturer Parent Company (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA