Events

Rappel de Next Generation 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 Alcon Laboratories, 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
    49600
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0274-2009
  • Date de publication de l'événement
    2008-11-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73896
  • 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
    Ophthalmic Laser - Product Code HQF
  • Cause
    Alcon had identified that indications for use unapproved by the food and drug administration are included in the purepoint laser system operator's manual, catalog number 8065751131, revision b.
  • Action
    An Alcon representative has been provided with a package of information for each customer site. All domestic customers are being provided an Urgent: Medical Device Correction letter describing the change to the PurePoint Operator's Manual and are being issued a revised PurePoint Operator's Manual (Revision C). The letter advises that Alcon Research, Ltd, has initiated a voluntary correction based upon unapproved indications for use identified within the Alcon PurePoint Laser System Operator's Manual, Revision B. The letter advises that the following indications for use have been updated or removed on page 1.14, Professional Operator's Information, in Revision C of the PurePoint Laser System Operator's Manual: Updated: "AMD; Wet or Dry to include macular degeneration" has been updated to read "Choroidal neovascularization secondary to age-related macular degeneration (AMD)". "Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG, POAG), Acute Angle Closure Glaucoma (AACG), and refractory glaucoma" has been updated to read "Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG, POAG) and refractory glaucoma" Removed: Macular photocoagulation; including grid, focal, laser drusen scatter (panretinal) Transcleral cyclophotocoagulation Intra-ocular tumors; to include choroidal hemangioma, choroidal melanoma, retinoblastoma Otosclerotic hearing loss. No other changes to the manual have been made in this revision and no other Alcon products are affected by this correction. Per the letter, an Alcon Representative will provide customers with a new PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Rev. C. and customers are return their existing PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Rev.B. A signed confirmation of receipt of the letter is required from all customers.

Device

Next Generation Laser
  • Modèle / numéro de série
    Serial Numbers 0801438901X, 0801481701X2, 0801591601X2, 0801591701X1, 0801591801X1, 0801692701X1, 0801717801X3, 0801717901X, 0801718001X1, 0801718101X, 0801718201X, 0801763401X1, 0801763601X, 0801817201X, 0801817601X, 0801844601X1, 0801844701X1, 0801844801X1, 0801844901X, 0801845001X1, 0801887201X, 0801887501X, 0801887601X, 0801965801X, 0801965901X, 0801966001X, 0802057301X, 0802057501X, 0802244501X, 0802244701X, 0802245101X, 0802480501X, 0802480901X, 0802484101X, 0802514101X, 0802529501X, 0802570101X, 0801887401X, 0802244301X, 0801439201X, and 0802244901X,
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- USA including states of IL, WI, TX, MI, PA, NY, CT, SC, NC, LA, FL, GA, CA, OR, WA, CO, and NV, and countries of India, Bulgaria, Barbados, and Dominican Republic.
  • Description du dispositif
    PurePoint System Operator's Manual, Catalog Number 8065751131, Rev. B for use with the Alcon PurePoint Laser, Catalog Number 8065750597 || Indicated for use in photocoagulation of both anterior and posterior segments of the eye.
  • Manufacturer
    Alcon Laboratories, Inc.

Manufacturer

Alcon Laboratories, Inc.
  • Adresse du fabricant
    Alcon Laboratories, Inc., 15800 Alton Pkwy, Irvine CA 92618
  • Société-mère du fabricant (2017)
    Novartis Ag
  • Source
    USFDA