Events

Rappel de Device Recall iSymm Intraocular Lens (Model FC60AD)

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 Hoya Surgical Optics, 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
    59207
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2801-2011
  • Date de mise en oeuvre de l'événement
    2011-06-17
  • Date de publication de l'événement
    2011-07-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-11-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101697
  • 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
    Intraocular lens - Product Code HQL
  • Cause
    The recall was initiated because hoya surgical optics has confirmed that the isymm intraocular lens (model fc-60ad) and isert intraocular lens (model pc-60ad) have been sold and marketed with out an fda approval.
  • Action
    Hoya Surgical Optics Inc. sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated June 22, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken. The letter instructs customers to quarantine affected product and return to HSO at their earliest convenience. Shipping instructions are included in the letter. Customers are to complete an Effectiveness Check Questionnaire and fax it to 1-909-680-3986. Questions regarding the recall process are directed to Hoya Customer Service at 1-866-750-5870 or e-mail at customercare@hoyasurgopt.com.

Device

Device Recall iSymm Intraocular Lens (Model FC60AD)
  • Modèle / numéro de série
    This recall pertains to all serial numbers of I-ISO Model FC-60AD & PC-60AD lenses shipped to the U.S. and affected by this recall. A list of all affected serial numbers will be provided to the FDA LA District office. The total number of products on recall are 4522 different serial numbers on a excel spread sheet that will be attached when the Recall recommendation is sent to CDRH.
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    iSymm Intraocular Lens (Model FC-60AD) || The Hoya iSymm Model FC-60AD Intraocular Lens (IOL) is an ultraviolet-light absorbing posterior chamber intraocular lens designed to be implanted posterior to the iris where the lens will replace the optical function of the natural crystalline lens. However, accommodation will not be replaced. The optic of this lens is designed to produce negative spherical aberration. The Hoya iSymm Model FC-60AD Intraocular Lens is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
  • Manufacturer
    Hoya Surgical Optics, Inc.

Manufacturer

Hoya Surgical Optics, Inc.
  • Adresse du fabricant
    Hoya Surgical Optics, Inc., 14768 Pipeline Ave, Chino Hills CA 91709-3594
  • Société-mère du fabricant (2017)
    Hoya Surgical Optics Inc.
  • Source
    USFDA