Events

Recall of Device Recall NeoMedix Trabectome I/A

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

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
    48721
  • Event Risk Class
    Class 2
  • Event Number
    Z-0071-2008
  • Event Initiated Date
    2007-05-28
  • Event Date Posted
    2008-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72004
  • 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
    surgical aspirator - Product Code BTA
  • Reason
    Failure of irrigation flow: the pinch valve in a few pumps may not consistently open to allow irrigation flow. in over 450 surgeries, the firm confirmed one instance of a valve that did not open. the electrically activated pinch valve in the neomedix trabectome i/a pump activates irrigation flow to the eye during trabectome surgery.
  • Action
    On May 31, 2007 NeoMedix mailed a Customer letter to all consignees informing them of the hazard. The letter also indicated to the customers they NeoMedix has developed a minor modification/upgrade that is designed to assure that the pinch valve opens at the appropriate time. The customers were instructed this modification requires return of their existing pump for modification and testing at the firm's facility before its return. In the event that surgeries have already been scheduled, NeoMedix will provide a loaner unit until the suspect unit can be modified and returned to you. The letter also indicated the cost of the modification and/or use of a loaner unit will be entirely at NeoMedix expense. You will be contacted to establish the details of implementing this modification.

Device

Device Recall NeoMedix Trabectome I/A
  • Model / Serial
    Model Number 550014; Lot Number 061205-1; Serial Numbers: 10117, 10119, 10120, 10122, 10124, 100129, and 10133.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide to: CA, HI, IA, NY & PA
  • Product Description
    NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator
  • Manufacturer
    Neomedix Corp

Manufacturer

Neomedix Corp
  • Manufacturer Address
    Neomedix Corp, 15042 Parkway Loop Ste A, Tustin CA 92780-6528
  • Manufacturer Parent Company (2017)
    Neomedix Corporation
  • Source
    USFDA