Events

Retiro De Equipo (Recall) de Device Recall Proclear

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por CooperVision Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    66844
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0543-2014
  • Fecha de inicio del evento
    2013-11-20
  • Fecha de publicación del evento
    2013-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124134
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Lens, contact, (disposable) - Product Code MVN
  • Causa
    Lots were labeled with incorrect expiration dates on secondary package (carton). the primary package (blister) is marked with the correct expiration date.
  • Acción
    CooperVision sent an Urgent Medical Device Recall Letters dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Our records indicate you received some of the affected product. Enclosed you will find a list of affected carton lot numbers, with the correct expiration date, that were shipped to your account. " Please immediately examine your inventory, " Stop any further distribution of carton(s) subject to the recall, " Quarantine carton(s) with incorrect expiration date, and " CooperVision will make arrangements to remove affected, quarantine product. As soon as possible, please complete the attached response form and fax it to 1.866.484.1048 or scan and email to info@coopervision.com. If you have product to return please contact customer service for instructions and to schedule pick-up and removal of affected, quarantined product. Your account will be credited once the product is returned and processed. We appreciate your assistance and apologize for any inconvenience you or your patients experienced by this removal. If you have any further questions, please feel free to contact us at 800-341-2020.

Device

Device Recall Proclear
  • Modelo / Serial
    Lot 446350083516, potential incorrect expiry date 6/2019; Lot 446450110928, potential incorrect expiry date 2/2019; Lot 446450173709, potential incorrect expiry date 4/2018; Lot 446450191100, potential incorrect expiry date 5/2019; Lot 446550083005, potential incorrect expiry date 5/2019; Lot 446550084607, potential incorrect expiry date 2/2018;  Lot 446650162408, potential incorrect expiry date 2/2018; Lot 446650177200, potential incorrect expiry date 2/2018; Lot 446650178110, potential incorrect expiry date 6/2017; Lot 446650179207, potential incorrect expiry date 6/2018; Lot 446750082713, potential incorrect expiry date 7/2019; Lot 446850029326, potential incorrect expiry date 4/2016; Lot 446850032905, potential incorrect expiry date 4/2016; Lot 446850129305, potential incorrect expiry date 1/2019; Lot 446850132713, potential incorrect expiry date 3/2019; Lot 446850133506, potential incorrect expiry date 6/2018; Lot 447050177419, potential incorrect expiry date 2/2018;  Lot 447050181906, potential incorrect expiry date 1/2017;  Lot 447050206016, potential incorrect expiry date 11/2019.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.
  • Descripción del producto
    ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, SO31 4RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA || daily use disposable contact lenses for astigmatism
  • Manufacturer
    CooperVision Inc.

Manufacturer

CooperVision Inc.
  • Dirección del fabricante
    CooperVision Inc., 180 Thruway Park Dr, W Henrietta NY 14586-9798
  • Empresa matriz del fabricante (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA