Events

Recall of Laser Loupes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kerr 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
    63516
  • Event Risk Class
    Class 2
  • Event Number
    Z-0414-2013
  • Event Initiated Date
    2012-04-10
  • Event Date Posted
    2012-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114115
  • 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
    Loupe, diagnostic/surgical - Product Code FSP
  • Reason
    The firm initiated the recall for laser loupes because the ink used to mark which laser frequency each laser loupe protects against may wipe off. the loupes work according to specification, but the marking may not permanently adhere to the device.
  • Action
    Customers were notified via USPS 1st class mail on April 10, 2012 to US and Canadian, and Rest of World (ROW) consignees, and on April 27, 2012 to European consignees. The notification letter identifies the product, reason for recall, and instructions to customers:"Please review the table below to verify that the laser loupes being used in your office has the correct filter color. ORASCOPTIC KINDLY REQUESTS YOUR COOPERATION IN COMPLETING AND FAXING BACK THE ENClOSED ACKNOWLEDGEMENT FORM IN ORDER TO CONFIRM YOUR RECEIPT OF THIS FIELD CORRECTION. If you are an authorized Orascoptic distributor, please inform your affected customers of this notification within forty-eight (48) hours of receipt.". Customer contact information was also provided:"Please contact Orascoptic Customer Care at 608.831.2555 or toll free in the United States and Canada at 1-800369- 3698 for more information.".

Device

Laser Loupes
  • Model / Serial
    The Laser Loupes are custom made-to-order products.   There are no general model, catalog, code, lot or serial numbers. Laser Loupes have no expiration date. The affected units were produced and distributed since September 2008.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the countries of Canada and EU.
  • Product Description
    The brand name of the device is Laser Loupes, a dentalloupe || with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. || Laser Loupes are || available with four (4) different filters of different colors. Each colored filter is || associated with specific laser frequency ranges. The device listing number for this product is E160359. || The intended use of this device is to magnify the operatory field and provide laser eye protection.
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation
  • Manufacturer Address
    Kerr Corporation, 3225 Deming Way, Middleton WI 53562
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA