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
    42834
  • Event Risk Class
    II
  • Event Initiated Date
    2012-11-15
  • 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
    Potential sterility failure of the paper pouch (supplied to rayner by an external company) that surrounds the intraocular lens blister tray. a failed pouch seal may cause the patient permanent serious injury and may cause severe infection and/or contribute to the development of toxic anterior segment syndrome (tass). tass can cause serious damage to intraocular tissues resulting in vision loss.

Device

T-FLEX TORIC HYDROPHILIC ACRYLIC LENS INJECTION SYSTEM PACK
  • Model / Serial
    Model Catalog: 623T (Lot serial: 102E4207204); Model Catalog: 623T (Lot serial: 102E4207203)
  • Product Description
    T-Flex Aspheric 623T
  • Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED

Manufacturer

RAYNER INTRAOCULAR LENSES LIMITED