Events

Recall of Device Recall OOptix (lotrafilcon B) Soft Contact Lenses

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ciba Vision Corporation.

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
    37113
  • Event Risk Class
    Class 2
  • Event Number
    Z-0427-2007
  • Event Initiated Date
    2007-01-11
  • Event Date Posted
    2007-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49932
  • 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
    Soft Contact Lenses - Product Code LPM
  • Reason
    Reduced ion permeability.
  • Action
    Consignees were notified by traceable mail on 01/12/2007. Consignees were advised to locate any of the affected lots and return them to CIBA Vision in accordance with the attached instructions. Returned lenses will be destroyed.

Device

Device Recall OOptix (lotrafilcon B) Soft Contact Lenses
  • Model / Serial
    All Lots starting with 6644001 through 6721262, with expiration dating of 2011/09 through 2011/11, and Lot numbers: 6626127, 6636101, 637017, 6637019, 6637103, 6640120, 6640124, 6642109, 6642119, 6642132 and 6643080, all with expiration dating of 2011/08.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide, Including USA, Canada, Australia, Benelux, UK and Germany
  • Product Description
    O¿Optix¿ (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3 lenses per package) and 6 packs (6 lenses per package).
  • Manufacturer
    Ciba Vision Corporation

Manufacturer

Ciba Vision Corporation
  • Manufacturer Address
    Ciba Vision Corporation, 11460 Johns Creek Pkwy, Duluth GA 30097-1518
  • Source
    USFDA