Events

Recall of APEX DAILY WEAR CONTACT LENSES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL CONTACT LENS 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
    45340
  • Event Risk Class
    III
  • Event Initiated Date
    2014-04-25
  • 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
    A number of units produced from onsi-56 batch #4291 have demonstrated dimensional instability in the form of base curve warpage and/or steepening occurring in post production potentially resulting in decreased visual performance.

Device

APEX DAILY WEAR CONTACT LENSES
  • Model / Serial
    Model Catalog: MESA (Lot serial: MATERIAL BATCH # 4291); Model Catalog: ASPHERIX CONE (Lot serial: MATERIAL BATCH # 4291); Model Catalog: ASPHERIX-2 (Lot serial: MATERIAL BATCH # 4291); Model Catalog: ASPHERIX-2K (Lot serial: MATERIAL BATCH # 4291); Model Catalog: BICURVE (Lot serial: MATERIAL BATCH # 4291); Model Catalog: TRILLIUM (Lot serial: MATERIAL BATCH # 4291); Model Catalog: TRICURVE (Lot serial: MATERIAL BATCH # 4291); Model Catalog: T.A.Z. (Lot serial: MATERIAL BATCH # 4291); Model Catalog: TRIADD (Lot serial: MATERIAL BATCH # 4291); Model Catalog: ASPHERIX-1 (Lot serial: MATERIAL BATCH # 4291); Model Catalog: JUNCTIONLESS CONE (Lot serial: MATERIAL BATCH # 4291); Model Catalog: FRONT TORIC (Lot serial: MATERIAL BATCH # 4291); Model Catalog: BITORIC (Lot serial: MATERIAL BATCH # 4291); Model Catalog: BACK TORIC (Lot serial: MATERIAL BATCH # 4291)
  • Product Description
    APEX DAILY WEAR CONTACT LENSES
  • Manufacturer
    CARDINAL CONTACT LENS INC.

Manufacturer

CARDINAL CONTACT LENS INC.