Events

Recall of Device Recall Insight Instruments MIS ( MultiPort Illumination System)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Insight Instruments, Inc..

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
    64887
  • Event Risk Class
    Class 2
  • Event Number
    Z-1281-2013
  • Event Initiated Date
    2013-03-15
  • Event Date Posted
    2013-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117276
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Cannula, Ophthalmic - Product Code HMX
  • Reason
    Insight instruments, inc., stuart, fl is recalling m.I.S. (multi-port illumination system), ophthalmic cannula due to a misclassification of the medical device.
  • Action
    Insight Instruments, Inc. sent a recall letter dated March 15, 2013, to all affected customers The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to do the following: 1)Perform a physical count of their inventory immediately for any of the recalled lots and complete and return the Return Response Form. 2) If they have any products listed, contact the firm at (800) 255-8354, to arrange for return and prompt replacement. 3) Discontinue using and dispensing all M.I.S. devices of the recalled lots.

Device

Device Recall Insight Instruments MIS ( MultiPort Illumination System)
  • Model / Serial
    Lot Numbers: M53157, M55115, M56929, M58551, M61862.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution IN and IL
  • Product Description
    Insight Instruments MIS ( Multi-Port Illumination System) || Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems.
  • Manufacturer
    Insight Instruments, Inc.

Manufacturer

Insight Instruments, Inc.
  • Manufacturer Address
    Insight Instruments, Inc., 2580 Se Willoughby Blvd, Stuart FL 34994-4701
  • Manufacturer Parent Company (2017)
    Insight Instruments, Inc.
  • Source
    USFDA