Events

Rappel de Device Recall Ocular Conformer

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 Porex Surgical, 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
    48722
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2302-2008
  • Date de mise en oeuvre de l'événement
    2008-03-28
  • Date de publication de l'événement
    2008-09-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-10-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72000
  • 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
    Conformer, ophthalmic - Product Code HQN
  • Cause
    The ocular conformers were distributed with an expired expiration date.
  • Action
    Consignees were contacted by phone on 03/28/2008. A follow up letter was sent on/about 03/31/2008. Consignees were instructed to examine their inventory and to quarantine Ocular Conformers containing the affected lots. These units should be returned to Porex Surgical using a Return Authorization Number provided. If the units were distributed, consignees were advised to contact their customers and inform them of the recall. They were informed the recall was being conducted to the physician level. Contact Porex Surgical at 1-770-515-7735 for assistance.

Device

Device Recall Ocular Conformer
  • Modèle / numéro de série
    Catalog number: 9574, Lot number 001061103C, Catalog number 9548, Lot number 002010204-C, Catalog number 9549, Lot number 003061103C, Catalog number 9779, Lot number 002050804C and Catalog number 9780, Lot number 006101204-C.
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    PA, Canada and Germany
  • Description du dispositif
    Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265. || The device is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process.
  • Manufacturer
    Porex Surgical, Inc.

Manufacturer

Porex Surgical, Inc.
  • Adresse du fabricant
    Porex Surgical, Inc., 15 Dart Rd, Newnan GA 30265-1017
  • Source
    USFDA