Events

Rappel de Device Recall Volk G4 Small Ring, No Flange, Gonio Lens with case

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 Volk Optical 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
    73213
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1177-2016
  • Date de mise en oeuvre de l'événement
    2016-02-02
  • Date de publication de l'événement
    2016-03-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143579
  • 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
    Lens, contact, polymethylmethacrylate, diagnostic - Product Code HJK
  • Cause
    The firm discovered that the incorrect lot number was engraved on the product.
  • Action
    Volk Optical sent an Urgent Medical Device Recall letter dated February 4, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine any affected product. Also, if product was further distributed customers should identify their customers and notify them at once of the product recall and include a copy of the letter. The affected devices should be returned to Volk with an assigned Return Merchandise Authorization (RMA) number. Customers should contact Volk at (440) 942-6161 or toll free at (800) 345-8655 as soon as they receive the notification to setup a RMA for their device(s). Customers were instructed to complete and return the enclosed response form as soon as possible. Customers with questions should call (440) 510-0745.

Device

Device Recall Volk G4 Small Ring, No Flange, Gonio Lens with case
  • Modèle / numéro de série
    Model #: VG4SNF, Lot: BE05200
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (Virginia only) Internationally to Canada, France & Indonesia.
  • Description du dispositif
    Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 || for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities
  • Manufacturer
    Volk Optical Inc

Manufacturer

Volk Optical Inc
  • Adresse du fabricant
    Volk Optical Inc, 7893 Enterprise Dr, Mentor OH 44060-5309
  • Société-mère du fabricant (2017)
    Halma Plc
  • Source
    USFDA