Events

Recall of CSI T (CROFILCON A) PROLONGED WEAR CONTACT LENS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CIBA VISION CORPORATION.

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
    98575
  • Event Risk Class
    III
  • Event Initiated Date
    2006-09-16
  • 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
    An increase in the number of poor vision complaints with csi lenses was observed. investigation showed the base curve to be steep which can cause vaulting on the eye and lead to reduced or fluctuating vision.

Device

CSI T (CROFILCON A) PROLONGED WEAR CONTACT LENS
  • Model / Serial
    Model Catalog: CSIT (Lot serial: ); Model Catalog: CSIS (Lot serial: ); Model Catalog: CSILTC (Lot serial: )
  • Product Description
    CSI Flexible Wear
  • Manufacturer
    CIBA VISION CORPORATION

Manufacturer

CIBA VISION CORPORATION
  • Manufacturer Address
    DULUTH
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    HC