Events

Retiro De Equipo (Recall) de Device Recall ClearSight 1Day Toric

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
    53532
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0125-2010
  • Fecha de inicio del evento
    2009-08-28
  • Fecha de publicación del evento
    2009-11-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85731
  • 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
    Disposable Contact Lens - Product Code MVN
  • Causa
    Thirty-eight lots of ocufilcon d 55% 1-day toric contact lens with a modified packaging solution sold under the brand name clearsight 1-day toric were inadvertently shipped into the us market prior to complete evaluation of the 510(k) by the fda.
  • Acción
    Urgent: Medical Device Recall - Contact Lens letters, dated 8/28/09, Response Forms, along with reorder forms and postage paid return labels were sent to the consignees via first class mail with instructions for returning the affected product. Customers are to examine their inventory and customer records to determine if they have any of the affected product. The affected products are to be returned and CooperVision will reimburse for all postage associated with the return and replace the lenses free of charge. Questions should be directed to Bonnie Tsymbal at (800) 341-2020 ext. 3210.

Device

Device Recall ClearSight 1Day Toric
  • Modelo / Serial
    Lot numbers: 446450034703 (Power -0075075090), 446850021203 (Power -0075125090), 446450034904 (Power -0100075090), 446450031005 (Power  -0125075090), 446450030905 (Power -0125075090), 46450031105 (Power -0125075090), 446850024806 (Power -0150125090), 447050023406 (Power  -0150125180), 447050022408 (Power -0200125180), 446450031509 (Power -0225075090), 447050024509 (Power -0225125180), 446650019310 (Power  -0250075180), 446650020510 (Power -0250075180), 447050022510 (Power -0250125180), 446650019411(Power -0275075180), 446650020611(Power -0275075180), 446650019512 (Power -0300075180), 447050022812(Power -0300125180), 447050022912 (Power -0300125180), 447050022712 (Power -0300125180), 446650019914 (Power -0350075180), 446650021314 (Power -0375075180), 446650019616 (Power -0400075180), 446650020816 (Power -0400075180), 447050023016 (Power -0400125180), 446650020017(Power -0425075180), 447050023117 (Power -0425125180), 447050023218(Power -0450125180), 447050024118 (Power -0450125180), 447050024718 (Power -0450125180), 446650020119 (Power -0475075180), 447050023319(Power -0475125180), 447050024219 (Power -0475125180), 447050021022(Power -0550125180), 447050021122 (Power -0550125180), 447050023522(Power -0550125180), 447050023624 (Power -0600125180), and 446650016926(Power -0650075180).
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and Address on Label: CooperVision Hamble, SO31 4RF, UK, and Scottsville, NY 14546 USA --- Each lens is supplied sterile in a blister containing buffered saline solution. The blister is labeled with the base curve, diameter, dioptric power, manufacturing lot number, and expiration date of the lens. ClearSight contact lenses are made from a material containing 55% water and 45% ocufilcon D, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling. || When placed on the cornea in its hydrated state, the ClearSight" (ocufilcon D) Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.
  • 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