Events

Recall of Device Recall STAR S4 IR Excimer Laser System; Software Version 5.21

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AMO Manufacturing USA, LLC.

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
    59330
  • Event Risk Class
    Class 2
  • Event Number
    Z-2973-2011
  • Event Initiated Date
    2011-07-18
  • Event Date Posted
    2011-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102308
  • 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
    Reports of lower success rates with iris registration (ir) image capture with the star s4 ir excimer laser system v 5.3 that with previous version.
  • Action
    Abbott Medical Optics (AMO) sent an "ADVISORY NOTICE" dated July 18, 2011 to all customers using the AMO WAVESCAN Wavefront System. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to create a separate patient file for each eye on the WAVESCAN System (STAR S4 IR Excimer Laser Systems,software versions 5.00-5.30) according to the directions in attachment A. Additionally, customers are to complete and return an attached form to AMO via fax at the regional fax number. Contact an AMO representative for questions regarding this notice.

Device

Device Recall STAR S4 IR Excimer Laser System; Software Version 5.21
  • Model / Serial
    Model # 0030-4825
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and countries of Africa, Asian Pacific, Canada, Europe, Japan, Latin America, and the Middle East.
  • Product Description
    STAR S4 IR Excimer Laser System; Software Version 5.21 || Mfg by : AMO Manufacturing USA, LLC || 510 Cottonwood Drive || Milpitas, CA 95035 || Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.
  • Manufacturer
    AMO Manufacturing USA, LLC

Manufacturer

AMO Manufacturing USA, LLC
  • Manufacturer Address
    AMO Manufacturing USA, LLC, 510 Cottonwood Dr, Milpitas CA 95035-7403
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA