Z-0414-2013Class II

The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been...

Name: Z-0414-2013 The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been...
Creator: Kerr Corporation
Published: 2012-04-10
License: https://open.fda.gov/license/

Metrex Research / initiated 2012-04-10 / Terminated

FDA source

Kerr Corporation began a recall of 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... on 2012-04-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0414-2013
Classification: Class II
Status: Terminated
Initiated: 2012-04-10
Posted: 2012-11-21
Terminated: 2012-11-21
Recalling firm: Metrex Research
Product: 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.
Product code: FSP Loupe, Diagnostic/Surgical
Reason for recall: 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.
FDA root cause: Finished device change control
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.".
Quantity in commerce: 639 units
Distribution: Worldwide Distribution--USA (nationwide) and the countries of Canada and EU.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0414-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0414-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21

Product code FSP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)