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U.S. Department of Health and Human Services

Class 2 Device Recall Laser Loupes

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 Class 2 Recall
Laser Loupes
see related information
Date Posted November 21, 2012
Recall Status1 Terminated on November 21, 2012
Recall Number Z-0414-2013
Recall Event ID 63516
Product Classification Loupe, Diagnostic/Surgical - Product Code FSP
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.
Code Information 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.
Recalling Firm/
Manufacturer
Kerr Corporation
3225 Deming Way
Middleton, Wisconsin 53562
Manufacturer 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 Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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