Events

Rappel de Device Recall ACUVUE ADVANCE Brand Contact Lens

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 Johnson & Johnson Vision Care, Inc..

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
    64468
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1336-2013
  • Date de mise en oeuvre de l'événement
    2012-12-21
  • Date de publication de l'événement
    2013-05-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116215
  • 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
    Lenses, soft contact, daily wear - Product Code LPL
  • Cause
    Limited number of individual contact lens packages may not have been completely sealed.
  • Action
    The firm, Johnson & Johnson, Vision Care, Inc. sent a letter dated January 9, 2013 to all their consignees stating the following actions: " Please contact your patients that may have received any of the affected product and instruct them to discontinue use immediately and return product to you for replacement " Please return the enclosed Business Reply Card (BRCl confirming for our records that you have received this notice, and indicating whether or not you have in stock, or have distributed to patients, any product from the lots noted above. " Please return any remaining affected product in your possession using the enclosed pre-paid mailer. " Pass this notice on to anyone in your practice that needs to be informed " Customer service will arrange for the return and replacement of any affected product. If you have any questions and/or if replacement lenses are needed, please contact customer Service (1-800-87 4-5278).

Device

Device Recall ACUVUE ADVANCE Brand Contact Lens
  • Modèle / numéro de série
    Lot Codes: B00DJPQ, -7.00D B00DMHZ, -6.00D B00DMJP, +4.00D
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and Puerto Rico; and countries of: Austria, Belgium, Canada, Costa Rica, Denmark, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea, Japan, Luxembourg, Netherlands, Portugal, Norway, South Africa, Slovenia, Spain, Sweden, and United Kingdom.
  • Description du dispositif
    ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. || The Vistakon (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less.
  • Manufacturer
    Johnson & Johnson Vision Care, Inc.

Manufacturer

Johnson & Johnson Vision Care, Inc.
  • Adresse du fabricant
    Johnson & Johnson Vision Care, Inc., 7500 Centurion Pkwy, Jacksonville FL 32256-0517
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA