Events

Recall of T-FLEX TORIC HYDROPHILIC ACRYLIC LENS INJECTION SYSTEM PACK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RAYNER INTRAOCULAR LENSES LIMITED.

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
    16713
  • Event Risk Class
    II
  • Event Initiated Date
    2016-01-07
  • 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
    Internal quality checks have revealed that certain products released to market may contain a higher than usual level of residual polishing compound (aluminium oxide) that is used in the manufacturing process of intraocular lenses (iols). rayner maintains extremely high levels of product quality and has set stringent internal limits for residual aluminium oxide levels. there is a possibility that certain products released to market may contain levels that slightly exceed these limits.

Device

T-FLEX TORIC HYDROPHILIC ACRYLIC LENS INJECTION SYSTEM PACK

Manufacturer

RAYNER INTRAOCULAR LENSES LIMITED