Events

Recall of Quick Care Starting Solution

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
    26932
  • Event Risk Class
    Class 3
  • Event Number
    Z-1234-03
  • Event Initiated Date
    2003-08-13
  • Event Date Posted
    2003-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28809
  • 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
    Accessories, Soft Lens Products - Product Code LPN
  • Reason
    Investigation has determined that the concentration of the isopropyl alcohol (ipa) decreased over time and may fall below specifications prior to reaching the expiration date.
  • Action
    The consignees were notified of the recall by letter on August 13, 2003 asking for return of the product.

Device

Quick Care Starting Solution
  • Model / Serial
    Lot No. 1278080, exp. date 5/2004
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CT, FL, GA, IA, KS, MI, MN, OH, and WI
  • Product Description
    Quick Care Starting Solution. The product is used for cleaning and disinfection of soft (hydrophilic) contact lenses.
  • Manufacturer
    Ciba Vision Corporation

Manufacturer

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