Events

Recall of Device Recall AMO Prestige Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Allergan Medical Optics 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
    28904
  • Event Risk Class
    Class 2
  • Event Number
    Z-0907-04
  • Event Initiated Date
    2004-03-29
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32748
  • 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
    The lots are being recalled because the tray lid may not be adequately sealed under the red arrow in the upper right corner of the package tray. the blue wrapping within the tray may not be sterile and may pose a potential risk of infection to the patient if used in a sterile field.
  • Action
    On March 31, 2004, a product notification letter was mailed to all customers via certified mail. The customers were instructed to stop using, quarantine and return all units. They were instructed to complete the Facsimile form provided and faxed it to the AMO Customer Service at 888-324-0021. They were also instructed to call AMO Customer Service at 800-366-6554 to make arrangement to return the product.

Device

Device Recall AMO Prestige Pack
  • Model / Serial
    Lot # Exp. date 3JR190 10/2006 3KR128 11/2006 3LR100 12/2006 3MR002 12/2006 3MR047 12/2006 3MR048 12/2006 3MR081 01/2007 3MR082 01/2007 4AR045 01/2007 4AR050 01/2007 4AR058 01/2007
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was to 67 domestic customers and internationally.
  • Product Description
    Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40
  • Manufacturer
    Allergan Medical Optics Inc

Manufacturer

Allergan Medical Optics Inc
  • Manufacturer Address
    Allergan Medical Optics Inc, 1700 E Saint Andrew Pl, Santa Ana CA 92705-4933
  • Source
    USFDA