Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Liberty Sport Slam, or MaxMorpheus

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Liberty Sport Slam, or MaxMorpheus see related information
Date Initiated by Firm November 24, 2009
Date Posted December 22, 2009
Recall Status1 Terminated 3 on October 27, 2010
Recall Number Z-0542-2010
Recall Event ID 53946
Product Classification Polycarbonate prescription lenses. - Product Code HQY
Product Polycarbonate prescription lenses (single vision, progressive, and trifocal) SKU #'s: 3703154, 4286102, 4286103, 4286104 and 4286106
Code Information The sunglasses SKU #'s: 3703154, 4286102, 4286103, 4286104 and 4286106
Recalling Firm/
Manufacturer		 Luxottica
4800 Luxottica Place
Mason OH 45040
Manufacturer 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.
FDA Determined
Cause 2		 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.
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.
-
-