Events

Rappel de Device Recall KAMRA INLAY

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 AcuFocus, 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
    73343
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1235-2016
  • Date de mise en oeuvre de l'événement
    2016-02-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143915
  • 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
    Implant, corneal, refractive - Product Code LQE
  • Cause
    Acufocus is recalling kamra aci 7000 corneal inlays due to concerns with the labeled shelf life.
  • Action
    The firm, AcuFocus, sent an "URGENT FIELD SAFETY NOTICE" letter dated 2/11/16 to all their customers to inform them that AcuFocus is recalling 2 lots of KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life. The described the product, problem and the actions to be taken. Customers are instructed to report any abnormal appearance of the implanted KAMRA inlay to AcuFocus, inc; stop using and remove from your inventory all affected lots; complete and return the attached Customer Recall Response Form via email: customerservice@acufocus.com, Fax: +1 (949) 585-9545 Attn: Recall Coordinator, or mail to: AcuFocus Inc., Attn: Recall Coordinator, 32 Discovery, Suite 200, Irvine CA 92618, within 3 business days even if you have no inventory affected by this recall; and provide the attached Customer Field Safety Notice and Customer Recall Response Form to your customers who have or may have received product from the affected two lots. Customers with product complaint events are instructed to report regarding KAMRA inlays involved in this recall event, and to inform AcuFocus, Inc. by calling +1 (949) 585-9511 ext 608. Customers with any questions related to the return process, are instructed to contact an AcuFocus Customer Service Representative at +1 (949) 585-9511 ext 608.

Device

Device Recall KAMRA INLAY
  • Modèle / numéro de série
    Lots A534-1014 and A535-1014
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.
  • Description du dispositif
    KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 || (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.
  • Manufacturer
    AcuFocus, Inc.

Manufacturer

AcuFocus, Inc.
  • Adresse du fabricant
    AcuFocus, Inc., 32 Discovery Ste 200, Irvine CA 92618-3161
  • Société-mère du fabricant (2017)
    AcuFocus Inc.
  • Source
    USFDA