Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0542-2010

Polycarbonate prescription lenses (single vision, progressive, and trifocal) SKU #'s: 3703154, 4286102...

Luxottica North America Distribution LLC / initiated 2009-11-24 / Terminated / root cause: manufacturing process

Luxottica began a recall of Polycarbonate prescription lenses (single vision, progressive, and trifocal) SKU #'s: 3703154, 4286102, 4286103, 4286104 and 4286106 on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0542-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Luxottica North America Distribution LLC
Product
Polycarbonate prescription lenses (single vision, progressive, and trifocal) SKU #'s: 3703154, 4286102, 4286103, 4286104 and 4286106
Product code
HQY Sunglasses (Non-Prescription Including Photosensitive)
Reason for recall
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 tag
manufacturing process
FDA 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 in commerce
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.
Product codes and lots
The sunglasses SKU #'s: 3703154, 4286102, 4286103, 4286104 and 4286106