||November 21, 2012
||Terminated on November 21, 2012
|Recall Event ID
Loupe, diagnostic/surgical -
||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.
||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.
3225 Deming Way
|For Additional Information Contact
|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
|Finished device change control
||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
||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.