Events

Recall of Device Recall MLS Torpedo MiniLight Ophthalmic singleport illumination

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
    66040
  • Event Risk Class
    Class 2
  • Event Number
    Z-0144-2014
  • Event Initiated Date
    2013-06-27
  • Event Date Posted
    2013-11-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121305
  • 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
    Punch, corneo-scleral - Product Code HNJ
  • Reason
    The product was registered and distributed as a class i medical device and was subsequently determined to be a class ii medical device which requires fda market clearance.
  • Action
    Insight Instruments, Inc. sent a letter dated April 8, 2013, via USPS priority mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue using and dispensing all affected product, perform a physical count of their inventory and complete the Return Response Form and fax to 772-219-9342. Customers were also instructed to call 800-255-8354 to arrange for return and prompt reimbursement. For questions regarding this recall call 727-219-9393.

Device

Device Recall MLS Torpedo MiniLight Ophthalmic singleport illumination
  • Model / Serial
    Part Number Lot Number Expiration 11007 M52934 04/2013 11017 M53017 04/2013 11007 M55285 07/2013 11007 M55869 08/2013 11007 M58610 12/2013 11007 M59575 02/2014 11007 M61781 05/2014
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including AZ, CA, FL, IN, MA, MD, TX, and WA and Internationally to Czech Republic, Germany, Netherlands, Spain, Switzerland, and Turkey.
  • Product Description
    MLS Torpedo Mini-Light Ophthalmic single-port illumination. || Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.
  • 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