Luxottica Optical Manufacturing: 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.

Recall number

Z-1568-2011

Recalling firm

Luxottica Optical Manufacturing

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.

Status

Terminated

Initiated

2010-06-30

Posted

2011-03-07

Terminated

2012-09-19

Reason

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.

Root 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

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.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

HQG

Firm FEI

3008153912

Firm city

Mason

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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