Events

Recall of Eyelite Laser

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alcon Research, Ltd..

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
    28883
  • Event Risk Class
    Class 2
  • Event Number
    Z-0923-04
  • Event Initiated Date
    2004-04-09
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32807
  • 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
    Laser, Ophthalmic - Product Code HQF
  • Reason
    Product may generate laser light flashback.
  • Action
    Additional in-service training materials have been prepared and will be delivered to users. Additional software upgrade will be made. Actvities will be complete in May 2004.

Device

Eyelite Laser
  • Model / Serial
    None
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Sweden, Taiwan, Fiji Islands, Cyprus, Philippines.
  • Product Description
    Opthalmic Laser, product number 8065-5000-1
  • Manufacturer
    Alcon Research, Ltd.

Manufacturer

Alcon Research, Ltd.
  • Manufacturer Address
    Alcon Research, Ltd., 6201 South Freeway, Fort Worth TX 76134-2099
  • Source
    USFDA