Events

Recall of COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER IOL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STAAR SURGICAL COMPANY.

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
    54260
  • Event Risk Class
    II
  • Event Initiated Date
    2004-02-26
  • 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
    Total number of 36 cases of hyperopic refractive changes were reported following implantation of 212156 single piece collamer iol's. may require seondary medical/surgical intervention.

Device

COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER IOL
  • Model / Serial
    Model Catalog: 4204BF (Lot serial: ); Model Catalog: 4205BF (Lot serial: )
  • Product Description
    Single-Piece Collamer Intraocular Lens
  • Manufacturer
    STAAR SURGICAL COMPANY

Manufacturer

STAAR SURGICAL COMPANY