Events

Recall of EASYFIT SLIT LAMP ADAPTER

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

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
    24591
  • Event Risk Class
    III
  • Event Initiated Date
    2004-08-13
  • 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 protective optic was reported to be loose and rattling around the inside of the 2p-esf body prior to installation of the opthalmic laser delivery device called easyfit slit lamp.

Device

EASYFIT SLIT LAMP ADAPTER
  • Model / Serial
    Model Catalog: (Lot serial: s/n EZZ7464)
  • Product Description
    EASYFIT ZEISS 30 SLIT LAMP ADAPTER
  • Manufacturer
    IRIDEX CORPORATION

Manufacturer

IRIDEX CORPORATION
  • Manufacturer Address
    MOUNTAIN VIEW
  • Source
    HC