Events

Recall of Staarvisic II || Sodium Hyaluronate, 0.8 mL

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Staar Surgical Co 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
    32798
  • Event Risk Class
    Class 2
  • Event Number
    Z-1106-05
  • Event Initiated Date
    2005-07-18
  • Event Date Posted
    2005-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40838
  • 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
    Aid, Surgical, Viscoelastic - Product Code LZP
  • Reason
    Sterility may be compromised.
  • Action
    Recall will be communicated by telephone, email and letter. A fax back form will be used to track response and to identify ammount on hand.

Device

Staarvisic II || Sodium Hyaluronate, 0.8 mL
  • Model / Serial
    Lot B041118C Exp Date 12/31/2005
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada and Puerto Rico
  • Product Description
    Staarvisic II || Sodium Hyaluronate, 0.8 mL
  • Manufacturer
    Staar Surgical Co Inc

Manufacturer

Staar Surgical Co Inc
  • Manufacturer Address
    Staar Surgical Co Inc, 1911 Walker Ave, Monrovia CA 91016-4846
  • Source
    USFDA