Events

Recall of Device Recall COMPLETE MultiPurpose Solution

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

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
    56735
  • Event Risk Class
    Class 2
  • Event Number
    Z-0129-2011
  • Event Initiated Date
    2010-07-23
  • Event Date Posted
    2010-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94408
  • 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
    Soft Lens Products Accessories - Product Code LPN
  • Reason
    The recall was initiated after amo determined, through internal testing, that a limited number of the flip top caps used during production of these solutions may leak and, although unlikely, the sterility of the product may be compromised. products that are non-sterile have the potential to cause eye infections, which may be sight threatening.
  • Action
    AMO prepared and issued on July 28, 2010 both a customer and distributor notification letter as part of their customer communication process. The letter informed the customers of the reason for recall, the products involved, the hazard involved and actions to be taken regarding the affected products. Customer with questions related to the COMPLETE Multi-Purpose Solution and/or Total Care (1) Contact Lens Solution return process, were instructed to contact an AMO Customer Service Representative at 1800 931 663.

Device

Device Recall COMPLETE MultiPurpose Solution
  • Model / Serial
    Lot Numbers: AH01202, AH01072, AH01223, AH01224, and AH01225.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International Distribution Only -- United Kingdom, Lebanon, Dubai, Bahrain, Russia, Kazakhstan, Ireland, and France.
  • Product Description
    AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). || Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.
  • Manufacturer
    Abbott Medical Optics Inc (AMO)

Manufacturer

Abbott Medical Optics Inc (AMO)
  • Manufacturer Address
    Abbott Medical Optics Inc (AMO), 1700 E Saint Andrew Pl, Santa Ana CA 92705
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA