Events

Recall of Device Recall Alcon 25 TOT ALPLUS Vitrectomv Pak

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alcon Research, LTD..

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
    79226
  • Event Risk Class
    Class 2
  • Event Number
    Z-0778-2018
  • Event Initiated Date
    2018-01-12
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161686
  • 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
    Unit, phacofragmentation - Product Code HQC
  • Reason
    Alcon is conducting this voluntary medical device recall for a specific lot (2060953h) of its 25+ totalplus vitrectomy pak due a potential that a 23ga ultravit probe may be included within the 25+ totalplus vitrectomy pak, instead of a 25+ ultravit probe.
  • Action
    Alcon sent an Urgent Field Safety Notice Recall notification letters to affected foreign medical users/distributors beginning January 12, 2018. For further questions please call (713) 668-9100.

Device

Device Recall Alcon 25 TOT ALPLUS Vitrectomv Pak
  • Model / Serial
    2060953H
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution : Argentina Australia France Italy Mexico Poland Spain Sweden Russia South Korea Ukraine
  • Product Description
    Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak || Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
  • Manufacturer
    Alcon Research, LTD.

Manufacturer

Alcon Research, LTD.
  • Manufacturer Address
    Alcon Research, LTD., 9965 Buffalo Speedway, Houston TX 77054-1309
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    USFDA