Events

Recall of Device Recall IPSAN patient bracelet

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alcon Laboratories, 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
    27748
  • Event Risk Class
    Class 2
  • Event Number
    Z-0229-04
  • Event Initiated Date
    2003-11-18
  • Event Date Posted
    2003-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30459
  • 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
    Gases Used Within Eye To Place Pressure On Detached Retina - Product Code LPO
  • Reason
    The firm initiated the recall on 11/18/2003 via letters to all consignees. the letter advises physicians to stop using any patient bracelets (blue color) that contain the word 'stickoxid', destroy all blue bracelets, and identify all patients who had either ispan gas administered who may still have a bubble present in the eye.
  • Action
    The patient bracelet that is given to patients post surgery after administering either ISPAN Perfluoropropane or ISPAN Sulfur Hexafluordie referred to the term, 'stickoxid', which is the general term for nitrogen oxide and may be interpreted as either nitrogen monoxide (NO) or dinitrogen monxoide. The firm is recalling the old (blue) bracelets and replacing them with new (grey) bracelets that now reference the specific term dinitrogen monoxide N20 (laughing gas).

Device

Device Recall IPSAN patient bracelet
  • Model / Serial
    All lots of the German translated patient bracelets
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Germany, Switzerland, and Austria
  • Product Description
    ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide
  • Manufacturer
    Alcon Laboratories, Inc

Manufacturer

Alcon Laboratories, Inc
  • Manufacturer Address
    Alcon Laboratories, Inc, 6600 South Fwy, Fort Worth TX 76134-2901
  • Source
    USFDA