Events

Recall of STAR Excimer Laser

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott 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
    66304
  • Event Risk Class
    Class 2
  • Event Number
    Z-0046-2014
  • Event Initiated Date
    2013-09-16
  • Event Date Posted
    2013-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121965
  • 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
    Excimer laser system - Product Code LZS
  • Reason
    This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the ac power distribution printed circuit board (pcb).
  • Action
    The firm, Abbott Medical Optics, Inc., (AMO), sent an "ADVISORY NOTICE and a COVER LETTER FOR ADVISORY NOTICE" dated September 16, 2013 to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. The customers were instructed to complete and return the Star Notification Acknowledgement form via fax to 1-714-247-4530 within 3 business days or mail to Abbott Medical Optics, 510 Cottonwood Drive, MS 347118, Milpitas, CA 95035, and share this advisory notice with your staff. If you have any questions related to operation of STAR Excimer Laser System or documentation requirements associated with this letter, please call AMO Technical Support at 1-800-511-0911 and you will be directed to an AMO Representative.

Device

STAR Excimer Laser
  • Model / Serial
    All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.
  • Product Description
    STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, || Milpitas, CA || The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
  • Manufacturer
    Abbott Medical Optics, Inc.

Manufacturer

Abbott Medical Optics, Inc.
  • Manufacturer Address
    Abbott Medical Optics, Inc., 510 Cottonwood Dr, Milpitas CA 95035-7403
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA