Events

Recall of CLARIS Cleaning and Soaking Solution, 4 fl. oz.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Medical Optics, Inc..

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
    32514
  • Event Risk Class
    Class 3
  • Event Number
    Z-0987-05
  • Event Initiated Date
    2005-06-13
  • Event Date Posted
    2005-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40225
  • 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
    Component mix-up of caps/tips. absence of red tip indicates improperly that the solution is safe for application to the eye.
  • Action
    Firm intiated recall to distributors on June 13, 2005 by letter.

Device

CLARIS Cleaning and Soaking Solution, 4 fl. oz.
  • Model / Serial
    Lot numbers: AA00785; AA00786: AA01050; AA01076
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Undetermined, assumed to be nationwide thru secondary distributors.
  • Product Description
    CLARIS Cleaning and Soaking Solution, 4 fl. oz.
  • Manufacturer
    Advanced Medical Optics, Inc.

Manufacturer

Advanced Medical Optics, Inc.
  • Manufacturer Address
    Advanced Medical Optics, Inc., 1700 E Saint Andrew Pl, Santa Ana CA 92705-4933
  • Source
    USFDA