Events

Recall of Alcon Custom Pak

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

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
    33409
  • Event Risk Class
    Class 2
  • Event Number
    Z-1575-05
  • Event Initiated Date
    2005-09-02
  • Event Date Posted
    2005-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41818
  • 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
    Lens, Surgical, Laser, Accesssory, Ophthalmic Laser - Product Code LQJ
  • Reason
    Unknown residue noted on suface of flap irrigators incorporated into cusom paks.
  • Action
    Firm notified consignee by letter on 9/2/2005.

Device

Alcon Custom Pak
  • Model / Serial
    Lot numbers: 520522H, 511655H, and 489635H
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Lake Charles, LA
  • Product Description
    Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless package is opened or damaged.RX Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in the firm''s Alcon Custom Pak Part Number 10162-01 under the description of dual tip irrigator, 8 ports, 16G.)
  • Manufacturer
    Alcon Research, Ltd

Manufacturer

Alcon Research, Ltd
  • Manufacturer Address
    Alcon Research, Ltd, 6201 South Fwy, Fort Worth TX 76134-2001
  • Source
    USFDA