Events

Rappel de COMPLETE MultiPurpose, 10 Minute, Comfort 8 in 1, Comfort Plus, and Protec

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 Advanced Medical 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
    36711
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0346-2007
  • Date de mise en oeuvre de l'événement
    2006-09-15
  • Date de publication de l'événement
    2007-03-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-02-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49675
  • 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
    contact lens solution - Product Code LPN
  • Cause
    Due to a potential sterility issue with the product container. three lots sold in japan were found to have bacterial contamination, which compromised sterility. because of this production-line issue at the firm''s plant in china, amo is recalling lots that were manufactured on the same production lines during the same production period.
  • Action
    Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall. Letters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006.

Device

COMPLETE MultiPurpose, 10 Minute, Comfort 8 in 1, Comfort Plus, and Protec
  • Modèle / numéro de série
    No US distribution
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.
  • Description du dispositif
    COMPLETE Multi-Purpose Solution (Asia Pacific markets, excluding Japan, Korea and Thailand), COMPLETE 10 Minute || (Japan only), Comfort 8 in 1 Solution (Indonesia only), || COMPLETE Comfort Plus All in One Solution (Korea only) & || COMPLETE Protec Formula Multi-Purpose Solution || (Thailand only)
  • Manufacturer
    Advanced Medical Optics, Inc.

Manufacturer

Advanced Medical Optics, Inc.
  • Adresse du fabricant
    Advanced Medical Optics, Inc., 1700 E Saint Andrew Pl, Santa Ana CA 92705-4933
  • Source
    USFDA