Events

Rappel de Device Recall Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear

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 The See Clear Company.

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
    76279
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1404-2017
  • Date de mise en oeuvre de l'événement
    2017-01-06
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152629
  • 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
    Sterility and misbranding: lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.
  • Action
    The firm, The See Clear Company, sent an "URGENT: DEVICE RECALL" letter dated 12/30/2016 to its Consignees on 01/06/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately examine your stock to determine if you have any of the listed product; immediately discontinue distributing the product and promptly return them via parcel post to Norcross facility, ATTENTION: RETURN GOODS; if you have further distributed any of the listed product, immediately contact your accounts, advise them of the recall, and have them return their outstanding recalled stocks to you; and immediately complete and return RECALL RETURN RESPONSE FORM via mail. If you have any questions, contact us at (678) 313-1399.

Device

Device Recall Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear
  • Modèle / numéro de série
    All lots of lenses sold between 10/31/2013 to 10/31/2016
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AZ, CA, DE, FL, GA, HI, LA, NJ, NY, NV, ON, PA and WA; and country of: Canada.
  • Description du dispositif
    Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
  • Manufacturer
    The See Clear Company

Manufacturer

The See Clear Company
  • Adresse du fabricant
    The See Clear Company, 4995 Buford Hwy Ste 102, Peachtree Corners GA 30071-2721
  • Source
    USFDA