Events

Recall of WaveLight FS 200 Femtosecond Laser System

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

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
    58601
  • Event Risk Class
    Class 2
  • Event Number
    Z-2292-2011
  • Event Initiated Date
    2011-04-18
  • Event Date Posted
    2011-05-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99665
  • 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
    keratome, ac-powered - Product Code HNO
  • Reason
    The software calculating the patterns were found to has a rounding error for certain parameter ranges. these rounding errors could result in an incomplete cut in the donor or patient tissue.
  • Action
    WaveLight AG sent an URGENT MEDICAL DEVICE CORRECTION letter April 18, 2011 to the affected customers. The letter identified the product, problem and the action to be taken by the customer. The letter advised the customers to discontinue keratoplasty cuts with the WaveLight FS200 until the new version can be installed. Alcon will contact you to schedule a visit of a service engineer at your site, to disable the keratoplasty function in your device, until a new software version can be installed to fix this problem. If you have experienced a product problem or adverse event related to this medical device correction, please contact Alcon Medical Safety at 1-800-561-6466, option 3. Customers were requested to complete the attached reply form to acknowledge receipt of this notification and fax it to ( 817) 916-9087.

Device

WaveLight FS 200 Femtosecond Laser System
  • Model / Serial
    Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including states of TX, KS, NC, CA, FL, OH, SC, MD, VA and NY and countries of Switzerland, Germany, Greece, United Kingdom, Ireland, Spain, Italy, Australia, India, Malaysia, France, Finland, Saudi Arabia, Czech Republic, Poland, China and South Korea and Iran.
  • Product Description
    WaveLight FS200 Femtosecond Laser System || Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2. || The WaveLight FS 200 Laser System is an ophthalmic surgical laser indicated for use in refractive surgery for LASIK flap cutting, lamellar and perforating keratoplasty, and intrastromal surgery for implants.
  • Manufacturer
    Wavelight AG

Manufacturer

Wavelight AG
  • Manufacturer Address
    Wavelight AG, Industriegebiet Doellnitz 5, Pressath Germany
  • Source
    USFDA