Events

Recall of Device Recall Liberty Sport Slam, or MaxMorpheus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Luxottica.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53946
  • Event Risk Class
    Class 2
  • Event Number
    Z-0542-2010
  • Event Initiated Date
    2009-11-24
  • Event Date Posted
    2009-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86905
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Polycarbonate prescription lenses. - Product Code HQY
  • 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.
  • 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.

Device

Device Recall Liberty Sport Slam, or MaxMorpheus
  • Model / Serial
    The sunglasses SKU #'s: 3703154, 4286102, 4286103, 4286104 and 4286106
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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 Description
    Polycarbonate prescription lenses (single vision, progressive, and trifocal) SKU #'s: 3703154, 4286102, 4286103, 4286104 and 4286106
  • Manufacturer
    Luxottica

Manufacturer

Luxottica
  • Manufacturer Address
    Luxottica, 4800 Luxottica Place, Mason OH 45040
  • Source
    USFDA