Events

Rappel de Device Recall Polycarbonate prescription single vision lenses for use in sport goggles.

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Luxottica Optical Manufacturing.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    56120
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1568-2011
  • Date de mise en oeuvre de l'événement
    2010-06-30
  • Date de publication de l'événement
    2011-03-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92699
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Lens, spectacle, non-custom (prescription) - Product Code HQG
  • Cause
    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.
  • 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.

Device

Device Recall Polycarbonate prescription single vision lenses for use in sport goggles.
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • 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.
  • Description du dispositif
    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.
  • Manufacturer
    Luxottica Optical Manufacturing

Manufacturer

Luxottica Optical Manufacturing
  • Adresse du fabricant
    Luxottica Optical Manufacturing, 4000 Luxottica Place, Mason OH 45040
  • Source
    USFDA