Events

Recall of CeeOn Heparin Surface

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
    33849
  • Event Risk Class
    Class 2
  • Event Number
    Z-0096-06
  • Event Initiated Date
    2005-10-05
  • Event Date Posted
    2005-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42554
  • 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
    A small opening (channel or tunnel) in the seal of the outer tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
  • Action
    A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.

Device

CeeOn Heparin Surface
  • Model / Serial
    CeeOn¿ One-Piece PMMA 722C, 10 lenses  PMMA HSM 722C +19,5 8094420508  8094430508  8094440508 PMMA HSM 722C +22,5 8032640508  8032830508  8032840508  8032850508 PMMA HSM 722C +23,0 8266000508 PMMA HSM 722C +23,5 8217920508 PMMA HSM 722C +28,5 8221020508  CeeOn¿ One-Piece PMMA 722Y, 2 lenses  PMMA HSM 722Y +29,0 8136600508  8136610508  CeeOn¿ One-Piece PMMA 811C, 1 lens  PMMA HSM 811C +22,0 8054190508  CeeOn¿ One-Piece PMMA 812CU, 4 lenses  PMMA HSM 812CU+17,5 8139760508 PMMA HSM 812CU+23,0 8156200508  8156210508  8156220508
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Austria, Belgium, Switzerland, Germany, Denmark, France, UK, Guadelope, Hong Kong, Croatia, India, Italy, Netherlands, and Vietnam
  • Product Description
    CeeOn Heparin Surface || Modified (HSM) PMMA One-Piebe Posterior Chambet- IOLs (Models:722C, 722Y, 811C, 812C and 812CU)
  • 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