Events

Recall of Collamer UV One-Piece IntraOcular Lens. || Models 4205BF and 4204BF

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
    28264
  • Event Risk Class
    Class 2
  • Event Number
    Z-0539-04
  • Event Initiated Date
    2004-02-09
  • Event Date Posted
    2004-02-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31464
  • 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
    Intraocular Lens - Product Code HQL
  • Reason
    Risk of hyperopic refractive changes.
  • Action
    Firm is distributing letters to physicians suggesting ways to mitigate the observed contracture of the eye tissues after implantation. Letters will be sent 2/9/2004.

Device

Collamer UV One-Piece IntraOcular Lens. || Models 4205BF and 4204BF
  • Model / Serial
    No codes apply
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide and to Australia, Canada, Chile, France, Germany, India, Lebanon, South Africa, Switzerland, United Kingdom.
  • Product Description
    Collamer UV One-Piece IntraOcular Lens. || Models 4205BF and 4204BF
  • 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