Events

Recall of STAR S4 IR EXCIMER LASER SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SALIENT MEDICAL SOLUTIONS.

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
    144513
  • Event Risk Class
    II
  • Event Initiated Date
    2011-07-25
  • 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
    Pupil centroid shift compensation is not functioning as intended in the iris registration (ir) software versions 5.00 through 5.30. as a result the center of the ablation pattern may not be optimally aligned. this may in some cases result in visual disturbances or reduced best corrected visual acuity.

Device

STAR S4 IR EXCIMER LASER SYSTEM
  • Model / Serial
    Model Catalog: STAR S4 IR (Lot serial: > 10 numbers contact mfg)
  • Product Description
    VISX EXCIMER LASER SYSTEM - STAR S4 IR
  • Manufacturer
    SALIENT MEDICAL SOLUTIONS

Manufacturer

SALIENT MEDICAL SOLUTIONS