Class 2 Device Recall Polycarbonate prescription single vision lenses for use in sport goggles.

• Date Initiated by Firm: June 30, 2010
• Date Posted: March 07, 2011
• Recall Status: Terminated on September 19, 2012
• Recall Number: Z-1568-2011
• Recall Event ID: 56120
• Product Classification: Lens, spectacle, non-custom (prescription) - Product Code HQG
• Product: Polycarbonate prescription single vision lenses for use in sport goggles. To be worn by a customer in a sport goggle frame to provide corrective refraction in accordance with the customer's prescription. Per the customer's request, some of the devices may also provide protection from bright sunlight.
• Code Information: In the U.S., the Liberty Sport frame models and the corresponding SKU numbers into which the lenses at issue were inserted are: MaxMorpheus - 3703097, 3703105, 3703121, 3703139, 3703154, 3703162; Slam - 4286102, 4286103; Rec Spec Maxx - 1292931, 2102549, 2102549, 2102556, 2102564, 2102606, 2621068, 2621076, 2621084, 3300266, 3300274, 3300282, 3300332, 3300340, 3300357; Rec Spec Zone - 2102622, 3300407; Rec Spec Fusion - 2102655, 2102663, 3300373; Rec Spec Matrix - 1270439, 1278090, 1278089; Rec Spec HS2C - 1260789; Rec Spec 2003 - 1278092; Rec Spec Soft Touch - 1260791 In Canada, the Liberty Sport frame models and the corresponding SKU numbers into which the lenses at issue were inserted are: MaxMorpheus - 3703097, 3703162; Rec Spec Maxx - 2102549, 2102556, 2621068, 2621076, 3300381.
• Recalling Firm/ Manufacturer: Luxottica Optical Manufacturing; 4000 Luxottica Place; Mason OH 45040
• For Additional Information Contact: Trenton W. Thomas; 513-765-6314
• Manufacturer Reason for Recall: The polycarbonate prescription lenses may not meet the frame manufacturer's minimum lens thickness specification of 2.0 millimeters. LNAD made the decision to remove these sport goggles from the market because of the potential risk that the lenses could break or disengage from the frame in the event of an impact.
• FDA Determined Cause: Other
• Action: Luxottica Optical Manufacturing sent notification letters on June 30, 2010, to their customers informing them of the problem. Customers were instructed to complete the enclosed Sport Goggle Return Form, and to indicate whether they would like a replacement pair of goggles or a refund. Place the completed Sport Goggle Return Form and their sport goggles (without the sport goggle case) in the envelope provided and return it to the firm via the United States Postal Service. Customers were instructed not to return to the retail store where purchased. If customers were unable to return their sport goggles because they were lost or discarded, customers should complete the appropriate information on the Sport Goggle Return Form, being sure to indicate whether they would like a replacement pair of goggles or a refund, and then sign the form. Place the completed Sport Goggle Return Form in the envelope provided and return it to the firm via the United States Postal Service. For any questions, call 1-877-488-2407. They instructed their customers to return the product for replacement or refund.
• Quantity in Commerce: 2,916 individual lenses (1,458 pair of sport goggles)
• Distribution: Worldwide Distribution - USA including the following states: AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI & WV; and the country of Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.