Events

Recall of PRO-PAK CUSTOM PACK FOR CATARACT AND SPECIALTY OPHTHALMIC PROCEDURES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by VALEANT CANADA LP/VALEANT CANADA S.E.C.

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
    152565
  • Event Risk Class
    II
  • Event Initiated Date
    2017-03-03
  • 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
    The company choose to initiate this recall due to higher than normal complaints of the laseredge product having a dull knife edge. some of the lots of laseredge knives have not been as sharp as previous lots of this product.

Device

PRO-PAK CUSTOM PACK FOR CATARACT AND SPECIALTY OPHTHALMIC PROCEDURES
  • Model / Serial
    Model Catalog: M99-0063-21671 (Lot serial: >10lots contact mgf); Model Catalog: M99-0063-21492 (Lot serial: >10lots contact mgf)
  • Product Description
    PRO-PAK CUSTOM PACK FOR CATARACT AND SPECIALTY OPHTHALMIC PROCEDURES
  • Manufacturer
    VALEANT CANADA LP/VALEANT CANADA S.E.C

Manufacturer

VALEANT CANADA LP/VALEANT CANADA S.E.C