Events

Rappel de Various Acuvue for Astigmatism Contact Lenses

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Pacific Pty Ltd.

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
    RC-2017-RN-01377-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-11-01
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01377-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Johnson & johnson vision care (jjvc) has identified quality issues identified with specific batches of acuvue contact lenses. a limited number of confirmed reports were received in relation to a foreign matter visible within the contact lens package and a lens being “off power”. foreign matter - a limited number of reports of a brush bristle found between the blister package and foil have been received.Off power - a limited number of confirmed reports of a lens being “off power” have been received, where a consumer may recognise as not accurately correcting the vision in one eye (some distortion or blurriness). not all lenses in these lots are affected and there is no significant health risk related to this issue.To date, there have been no adverse events related to these issues.
  • Action
    Eye Care Professionals are advised to check stock and quarantine the affected lot numbers. Affected stock can be returned for unaffected product.

Device

Various Acuvue for Astigmatism Contact Lenses
  • Modèle / numéro de série
    Various Acuvue for Astigmatism Contact LensesAcuvue Oasys for Astigmatism, 8.6 -6.00 -1.75/170 6P and 8.6 -3.50 -0.75/180 6PLot Numbers: B00GW4Z and B00HRMGExpiry: Nov 2018 and Jul 2019Acuvue Oasys, 8.8 -04.00 6P RXLot: L002NCSExpiry: May 2020Acuvue Oasys, 8.8 -04.50 6PLot: L002QH9Expiry: Aug 20201 Day Acuvue Moist for Astigmatism, 8.5 -7.50 -1.25/180 90PLot: F00LF41Expiry: Apr 2021ARTG Numbers: 223534, 223535, 223536 and 154490
  • Manufacturer
    Johnson & Johnson Pacific Pty Ltd

Manufacturer

Johnson & Johnson Pacific Pty Ltd