Recall Z-0542-2010 ยท HQY Sunglasses (Non-Prescription Including Photosensitive)
Luxottica
Polycarbonate prescription lenses (single vision, progressive, and trifocal) SKU #'s: 3703154, 4286102, 4286103, 4286104 and 4286106
| Date | Dec 22, 2009 (initiated Nov 24, 2009) |
| Status | Terminated |
| Reason | The lenses made for sunglass frames (Liberty Sport Slam or MaxMorpheus) do not meet the lens thickness specification established by the frame manufacturer. The lens thickness range from 1.0 to 1.9 millimeters instead of the required 2.0 millimeter minimum. There is a potential risk that the lenses could break or disengage from the frame in the event of an impact. |
| Root cause | Employee error |
| Action | On 11/24/2009 the firm sent recall notification letters to their customers indicating the problem with the lenses. they instructed their customers return the product to the place of purchase for replacement or refund. Questions are directed to the firm at 1-877-488-2407 from 8:00 a.m. to 5:00 p.m. ET. |
| Quantity | 276 polycarbonate prescription lenses (138 pairs of lenses) |
| Distribution | Product was distributed to the following states: AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, & WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.