Events

Rappel de INTRALASE FS Laser

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 AMO Manufacturing USA, LLC.

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
    60241
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0165-2012
  • Date de mise en oeuvre de l'événement
    2011-10-12
  • Date de publication de l'événement
    2011-11-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-05-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104853
  • 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
    Keratome, ac-powered - Product Code HNO
  • Cause
    The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.G. 300 ¿m or deeper) created using the laser system.
  • Action
    Abbott Medical Optics Inc. (AMO) issued an "ADVISORY NOTICE" letter dated October 12, 2011 to all affected customers. The letter identifies the affected products, the problem, and the actions needed to be taken. Customers were instructed to exercise caution when making cuts that approach the corneal endothelium. The letter includes a 1-page Operator's Manual addendum that clarifies the recommendations. The letter states that AMO will conduct a field correction to adjust the EOF on the affected FS Laser Systems. The letter includes a response form to be completed and returned as per the instructions. Customers were instructed to notify all appropriate staff/personnel of the Advisory Notice. For any further questions regarding the information or recommendations, contact an AMO representative at 1-800-266-3375

Device

INTRALASE FS Laser
  • Modèle / numéro de série
    All units of these models (models 2, 3 and iFS) except model 1.
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide)
  • Description du dispositif
    Abbott brand Advanced Femtosecond Laser Systems, Model iFS, Catalog Number: J20007D/J/K; || Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA || Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.
  • Manufacturer
    AMO Manufacturing USA, LLC

Manufacturer

AMO Manufacturing USA, LLC
  • Adresse du fabricant
    AMO Manufacturing USA, LLC, 510 Cottonwood Dr, Milpitas CA 95035-7403
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA