Events

Recall of TECNIS 1-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AMO CANADA COMPANY.

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
    30971
  • Event Risk Class
    II
  • Event Initiated Date
    2009-11-12
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The tecnis 1-piece intraocular lenses (iols) are being recalled because the haptics of some tecnis 1-piece iols (model zcb00) have adhered to the lens optic after insertion into the eye. this situation can lead to additional manipulation to separate the haptics from the optic during surgery which could lead to an injury.

Device

TECNIS 1-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS
  • Model / Serial
    Model Catalog: ZCB00 (Lot serial: )
  • Product Description
    TECHNIS 1-PIECE POSTERIOR CHAMBER IOL
  • Manufacturer
    AMO CANADA COMPANY

Manufacturer

AMO CANADA COMPANY