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

FDA device recall Z-0414-2013 · posted 2012-11-21 · Terminated

Recall details

Recalling firm

Kerr Corporation

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.

Action taken

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.".

Root cause

Finished device change control

Status

Terminated

Product code

FSP

Quantity affected

639 units

Distribution

Worldwide Distribution--USA (nationwide) and the countries of Canada and EU.

Date initiated

2012-04-10

Date posted

2012-11-21

Date terminated

2012-11-21

Location

Middleton, WI