Events

Rappel de Lumenis

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 Lumenis, 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
    69139
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2733-2014
  • Date de mise en oeuvre de l'événement
    2014-08-15
  • Date de publication de l'événement
    2014-09-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129733
  • 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
    Laser, ophthalmic - Product Code HQF
  • Cause
    Lumenis initiated a field-correction for the array laser link", ga-0006700 (sn xxyyzz) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern.
  • Action
    Lumenis sent a Safety Advisory Notice dated July 15, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed that Lumenis would contact consignees to schedule a product update, to be completed at a convenient time. For questions consignees should call 801-656-2549. For questions regarding this recall call 801-656-2690.

Device

Lumenis
  • Modèle / numéro de série
    All assembled units since product release, Part Number: GA-0006700.
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA.
  • Description du dispositif
    Array LaserLink, Manufactured by Lumenis, || The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural Abnormalities of the Retina and Choroid including: " Proliferative and Severe and Very Severe Non-Proliferative Diabetic Retinopathy " Macular Edema associated with Proliferative or Non-Proliferative Diabetic Retinopathy " Choroidal Neovascularization " Retinal Neovascularization associated with Retinal Occlusive Disease (Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion) " Macular Edema associated with Branch Retinal Vein Occlusion " Retinal Tears and Detachments And Anterior Segments as follows: " Iridotomy in Closed Angle Glaucoma " Trabeculoplasty in Open Angle Glaucoma
  • Manufacturer
    Lumenis, Inc.

Manufacturer

Lumenis, Inc.
  • Adresse du fabricant
    Lumenis, Inc., 3959 W 1820 S, Salt Lake City UT 84104
  • Société-mère du fabricant (2017)
    Laguna Holdco Ltd
  • Source
    USFDA