Events

Rappel de WaveLight FS 200 Femtosecond Laser System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Wavelight AG.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    58601
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2292-2011
  • Date de mise en oeuvre de l'événement
    2011-04-18
  • Date de publication de l'événement
    2011-05-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99665
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    keratome, ac-powered - Product Code HNO
  • Cause
    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
  • Modèle / numéro de série
    Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Wavelight AG, Industriegebiet Doellnitz 5, Pressath Germany
  • Source
    USFDA