Events

Recall of Device Recall CIBA Vision contact lens

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
    26077
  • Event Risk Class
    Class 3
  • Event Number
    Z-0787-03
  • Event Initiated Date
    2003-01-17
  • Event Date Posted
    2003-05-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-05-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27016
  • 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
    Lenses, Soft Contact, Extended Wear - Product Code LPM
  • Reason
    Freshlook 'colors' contact lenses were incorrectly packaged into a freshlook 'colorblends' carton.
  • Action
    Consignees were notified via letter on January 17, 2003. They were advised to return any of the affected lot to CIBA Vision for replacement.

Device

Device Recall CIBA Vision contact lens
  • Model / Serial
    Lot number 064429, Expiration date, 2006/11
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    The product was distribured to wholesalers located in AL, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NJ, NY, OH, OK, OR, PA, TX, UT, WA, and WI.
  • Product Description
    FreshLook Colors (phemfilcon A), 7-day Extended wear soft (hydrophilic) contact lens, Violet, SPH -0.75, Lot 064429, 2006-11, BC: Median DIA: 14-5, Rx only, CIBA Vision Corp., Duluth, GA 30097, USA. The product was distributed in multi-packs (cartons of six lenses each).
  • Manufacturer
    Ciba Vision Corporation

Manufacturer

Ciba Vision Corporation
  • Manufacturer Address
    Ciba Vision Corporation, 11440 Johns Creek Parkway, Duluth GA 30097
  • Source
    USFDA