Events

Recall of SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER IOL

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
    79813
  • Event Risk Class
    II
  • Event Initiated Date
    2015-03-06
  • 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
    Based on a limited number of complaints received for broken haptics during lens loading and insertion an investigation was initiated. this investigation resulted in bausch & lomb determining that a portion of a lot of haptic material is performing differently than other lots in term of material elongation properties.

Device

SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER IOL
  • Model / Serial
    Model Catalog: LI61AO (Lot serial: > 1000 contact Manufacturer); Model Catalog: LI61SE (Lot serial: > 1000 contact Manufacturer)
  • Product Description
    SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER IO
  • Manufacturer
    VALEANT CANADA LP/VALEANT CANADA S.E.C

Manufacturer

VALEANT CANADA LP/VALEANT CANADA S.E.C