Events

Recall of Device Recall STAAR Surgical Collamer UltravioletAbsorbing Posterior Chamber Single

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Staar Surgical Co..

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
    59028
  • Event Risk Class
    Class 2
  • Event Number
    Z-2706-2011
  • Event Initiated Date
    2011-05-20
  • Event Date Posted
    2011-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100868
  • 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
    The recall was initiated by staar surgical due to an error in the directions for use (dfu) for staar surgical's collamer ultraviolet absorbing posterior chamber single piece foldable intraocular lens (collamer ip iol), also known as the nanoflex iol. the device description erroneously indicates that the lens could be implanted in the ciliary sulcus.
  • Action
    Staar Surgical send out an URGENT - Medical Device Correction Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to acknowledge receipt of the letter by signing, dating, and faxing the form to Staar Surgical. For any questions call (800) 292-7902, ext 2345.

Device

Device Recall STAAR Surgical Collamer UltravioletAbsorbing Posterior Chamber Single
  • Model / Serial
    CC4204BF and CC4204A
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of South Africa, Slovakia, Mexico, Hong Kong, and Sri Lanka
  • Product Description
    Brand Name || STAAR Surgical Collamer¿ Ultraviolet-Absorbing Posterior Chamber Single || Piece Foldable Intraocular Lens || Common Names || Collamer single piece IOL || Collamer plate haptic IOL || The Device is intended to correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The Device is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy).
  • Manufacturer
    Staar Surgical Co.

Manufacturer

Staar Surgical Co.
  • Manufacturer Address
    Staar Surgical Co., 1911 Walker Ave, Monrovia CA 91016-4846
  • Manufacturer Parent Company (2017)
    Staar Surgical Co.
  • Source
    USFDA