Events

Recall of Device Recall AQuify

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
    33960
  • Event Risk Class
    Class 2
  • Event Number
    Z-0182-06
  • Event Initiated Date
    2005-11-02
  • Event Date Posted
    2005-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42803
  • 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
    Products, Contact Lens Care, Rigid Gas Permeable - Product Code MRC
  • Reason
    Lack of assurance of sterility at the time of manufacture.
  • Action
    Consignees were contacted by telephone with a follow up letter 11/04/2005.

Device

Device Recall AQuify
  • Model / Serial
    Lot #52246
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, Germany, Benelux, and the UK
  • Product Description
    AQuify¿ Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Lenses * 1/3 fl. Oz. (10mL) * Sterile * CIBA Vision Corp. Made In Canada Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA
  • Manufacturer
    Ciba Vision Corporation

Manufacturer

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