Events

Recall of LENTIS COMFORT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CLARION MEDICAL TECHNOLOGIES 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
    72650
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-03
  • 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
    Due to an increase of opacification complaints oculentis initiated a study to investigate the sporadic late postoperative opacification of lentis iols (completed august 30 2017). the results of our study have indicated that surface calcification could possibly be the result of phosphate remnants originating from a phosphate containing detergent previously used in the cleaning process of the iol from january 2012 -may 2015.

Device

LENTIS COMFORT
  • Model / Serial
    Model Catalog: LS-313 MF30 (Lot serial: all S/N before expiry 05/2020); Model Catalog: LS-313 MF15 (Lot serial: all S/N before expiry 05/2020)
  • Product Description
    LENTIS COMFORT;LENTIS MPLUS X INTRAOCULAR LENS;LENTIS MPLUS INTRAOCULAR LENS
  • Manufacturer
    CLARION MEDICAL TECHNOLOGIES INC.

Manufacturer

CLARION MEDICAL TECHNOLOGIES INC.