Events

Recall of Device Recall AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced 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
    36943
  • Event Risk Class
    Class 2
  • Event Number
    Z-0148-2007
  • Event Initiated Date
    2006-11-29
  • Event Date Posted
    2006-12-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49638
  • 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
    Intraocular Lens - Product Code HQL
  • Reason
    The lenses are incorrectly labeled as 11 diopter lenses; these lenses are actually 22.5 diopters.
  • Action
    On November 13, 2006, an 'URGENT MEDICAL DEVICE RECALL' letter was mailed to all affected US customers communicating their recall strategy regarding the removal of five (5) ZA9003 lenses in US distribution. This letter included in this correspondence is a listing of the serial numbers and the quantities of intraocular lenses shipped. This listing will act as your Facsimile Form to be returned to AMO for accountability of the lenses shipped to your facility. AMO will ensure the effectiveness of the recall by using a return facsimile form to capture the status of each of the lenses.

Device

Device Recall AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses
  • Model / Serial
    Serial numbers: 531644065, 5316450605, 5316460605, 5316470605, 5316490605, 5316500605, and 5316510605
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide, including USA (CT, TX, NY), Canada, and UK.
  • Product Description
    AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses
  • Manufacturer
    Advanced Medical Optics, Inc.

Manufacturer

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