Events

Recall of Next Generation Laser

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alcon Laboratories, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    49600
  • Event Risk Class
    Class 2
  • Event Number
    Z-0274-2009
  • Event Date Posted
    2008-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73896
  • Notes / Alerts
    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.
  • Extra notes in the data
    Ophthalmic Laser - Product Code HQF
  • Reason
    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
  • Model / Serial
    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,
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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.
  • Manufacturer Address
    Alcon Laboratories, Inc., 15800 Alton Pkwy, Irvine CA 92618
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    USFDA