Events

Recall of SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft 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
    30159
  • Event Risk Class
    Class 2
  • Event Number
    Z-0028-05
  • Event Date Posted
    2004-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35285
  • 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
    Stability tests at 24 months revealed failing results for disinfection efficacy.
  • Action
    Consignees were notified by letter on 10/01/2004.

Device

SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose ...
  • Model / Serial
    All sizes, configurations and all third part branded products
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, Latin America, Europe, Thailand, South Africa and Asia.
  • Product Description
    SOLO-care¿ Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.
  • Manufacturer
    Ciba Vision Corporation

Manufacturer

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