Events

Recall of Healon D

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
    50179
  • Event Risk Class
    Class 1
  • Event Number
    Z-0343-2009
  • Event Initiated Date
    2008-10-29
  • Event Date Posted
    2008-12-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74908
  • 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 viscosurgical device - Product Code LZP
  • Reason
    Endotoxin levels above specifications have been noted in some syringes tested for lot number ud30654 of the amo healon d ophthalmic viscosurgical device. endotoxin levels above the maximum usp level may be potential causes of an inflammatory response and/or tass in patients following surgery.
  • Action
    On Thursday, October 30, 2008, AMO began distribution of an Urgent Device Recall Notice via Federal Express overnight delivery to the twenty-six (26) AMO Healon D OVD, Lot UD30654, customer accounts in the United States. The Urgent Device Recall Notice include& a facsimile reply form. The Recall Notice informed the customers that AMO has received reports that some physicians using lot number UD30654 of the AMO Healon D OVD have observed an inflammatory reaction in their patients at the one-day post-operative visit. The customers were asked to undertake the following actions: (1) STOP using and remove from your inventory all units of AMO Healon D OVD, Lot UD30654. (2) Complete the included Facsimile Form making sure to note on the Facsimile Form the Quantities of AMO Healon D OVD present in your facility to be returned to AMO and fax to AMO Customer Service at 714-247-8722 within the next three (3) business days. The customers were also informed that an AMO Customer Service Representative will be contacting them to assist with the return of product affected by this action. If they have AMO Healon DC OVD units to be returned as part of this recall event and have not been contacted by an AMO Customer Service Representative, please call our toll free number at 1-877-AMO-4LIFE (1-877-266-4543) so that we can arrange the return of the product.

Device

Healon D
  • Model / Serial
    Lot Number: UD30654
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide to: MA, NJ, NY, WV, NC, SC, KY, OH, IN, MI, MN, OK, TX, WY OR, WA and Puerto Rico
  • Product Description
    AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, Lot Number: UD30654, 30 mg/mL fill size
  • 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
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA