Events

Recall of 25 GA Total Plus Pak

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
    51964
  • Event Risk Class
    Class 2
  • Event Number
    Z-1643-2009
  • Event Initiated Date
    2009-04-29
  • Event Date Posted
    2009-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81781
  • 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
    Ophthalmic Trocar Cannula - Product Code NGY
  • Reason
    Specific lots of alcon 25 ga trocar blades do not conform to finished product specifications in that oxidation can occur on some of the blades.
  • Action
    Firm began notifying consignees of recall by Urgent: Medical Device Recall letter on 04/29/09 (letters sent via FedEx). Consignees instructed to check inventory for affected lots; to complete and return the Medical Device Recall Response Form; to contact Alcon to arrange for return of the devices; that credit will be issued for the recalled product when it is returned; and in the case that there is no inventory remaining, to indicate that on the Response Form and return it as well. Consignees should contact Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8 for technical assistance.

Device

25 GA Total Plus Pak
  • Model / Serial
    Lot #9013991X, 9014291X and 9014509X.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Canada.
  • Product Description
    Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.
  • Manufacturer
    Alcon Laboratories, Inc

Manufacturer

Alcon Laboratories, Inc
  • Manufacturer Address
    Alcon Laboratories, Inc, 6201 South Fwy, Fort Worth TX 76134
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    USFDA