Rappel de Device Recall Alcon Lux OR LX3 Microscope Floor Stand

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 Alcon Research, Ltd..

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
    77480
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3081-2017
  • Date de mise en oeuvre de l'événement
    2017-05-25
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Microscope, operating & accessories, ac-powered, ophthalmic - Product Code HRM
  • Cause
    Multiple shipments or forceful impact to a caster on a luxor/lx3 microscope may stress the microscope base, which could contribute to a caster breaking or detaching from the base.
  • Action
    Alcon sent an Urgent Medical Device Correction letter dated May 25, 2017, to all affected customers. Demonstration units in inventory will be scheduled for retrofit of base and/or upgraded caster configuration through onsite service calls. Customers with questions or concerns were instructed to call 1-800-832-7827. For questions regarding this recall call 817-293-0450.

Device

  • Modèle / numéro de série
    Domestic Serial Numbers: 1402548501X, 1402548502X, 1402548503X, 1402548504X, 1402548505X, 1402548506X, 1402577401X, 1402577402X, 1402577403X, 1402577404X, 1402577405X, 1402577406X, 1402612001X, 1402612002X, 1402612003X, 1402612004X, 1402612005X, 1402612006X, 1402655703X, 1402655704X, 1402655705X, 1402655706X, 1402705203X, 1402705204X, 1402728703X, 1402728704X, 1402728705X, 1402728706X, 1402804805X, 1402804806X, 1402887601X, 1402887602X, 1402887603X, 1402887604X, 1402959002X, 1402959004X, 1402959005X, 1402959006X, 1403012601X, 1403012602X, 1403012603X, 1403012604X, 1403012605X, 1403012606X, 1403045903X, 1403045904X, 1403045905X, 1403045906X, 1403072801X, 1403072802X, 1403072803X, 1403072804X, 1403072805X, 1403072806X, 1403124901X, 1403124902X, 1403124903X, 1403124904X, 1403124905X, 1403124906X, 1403145301X, 1403145302X, 1403145303X, 1403145304X, 1403145305X, 1403145306X, 1403173401X, 1403173402X, 1403173403X, 1403173404X, 1403173405X, 1403173406X, 1403211701X, 1403211702X, 1403211704X, 1403211706X, 1403239601X, 1403239602X,  1403239603X, 1403239604X, 1403239605X, 1403239606X, 1403253702X, 1403253703X, 1403253705X, 1403253706X, 1403272701X, 1403272702X, 1403351301X, 1403351302X, 1403351303X, 1403351304X, 1403351305X, 1403351306X, 1403390506X, 1403390803X, 1403390805X, 1403440402X, 1403440406X, 1403440502X, 1403440503X, 1403440505X, 1403440506X, 1403484502X, 1403484602X, 1403484603X, 1403484604X, 1403539702X, 1403539703X, 1403539704X, 1403539706X, 1403625401X, 1403625402X,  1403625403X, 1403625404X, 1403625405X, 1403625406X, 1403625501X, 1403625502X, 1403625504X, 1403625505X, 1403688701X, 1403688702X,  1403688801X, 1403688802X, 1403688803X, 1403688804X, 1403688805X, 1403688806X, 1403736301X, 1403736302X, 1403736303X, 1403736304X, 1403736305X, 1403736306X, 1403736401X, 1403736404X, 1403791801X, 1403791803X, 1403791805X, 1403791806X, 1403830904X, 1403830905X, 1403830906X, 1403831004X, 1403831005X, 1403831006X, 1403862204X, 1403862205X, 1403862206X, 1403862305X, 1403862306X, 1403886401X,  1403886402X, 1403886403X, 1403886404X, 1403886405X, 1403886406X, 1403886501X, 1403886502X, 1403886503X, 1403886504X, 1403886505X, 1403886506X, 1403986603X, 1403986604X, 1403986605X, 1403986606X, 1403990601X, 1403990602X, 1403990603X, 1403990604X, 1403990701X, 1403990703X, 1403990704X, 1403990705X, 1403990706X, 1404022104X, 1404022105X, 1404022202X, 1404022204X, 1501030401X, 1501030601X, 1501030606X, 1501088001X, 1501088006X, 1501088101X, 1501088105X, 1501088106X, 1501132903X, 1501132905X, 1501132906X, 1501158301X, 1501158302X, 1501158303X, 1501158304X, 1501158401X, 1501158402X, 1501158403X, 1501158404X, 1501158406X, 1501201501X, 1501201506X, 1501274503X, 1501355602X, 1501355603X, 1501355604X, 1501355605X, 1501355606X, 1501355702X, 1501565905X, 1501566001X, 1501566003X, 1501566004X, 150156600SX, 1501566006X, 1501619502X, 1501619503X, 1501619506X, 1501619601X, 1501619604X, 150161960SX, 1501619606X, 1501646804X, 1501646902X, 1501646903X, 1501646906X, 1501672006X, 1501672102X, 1501672105X, 1501672106X, 1501731601X, 1501731602X, 1501731604X, 1501731805X, 1501731806X, 1501790001X, 1501790002X, 1501790003X, 1501790004X, 1501790005X, 1501790006X, 1501790103X, 1501790104X, 1501790105X, 1501790106X, 1501838401X, 1501838402X, 1501838403X, 1501838404X, 1501838405X, 1501838406X, 1501898901X, 1501898902X, 1501898903X, 1501898904X, 1501898905X, 1501899003X, 1501899006X, 1501940101X, 1501940102X, 1501940104X, 1501940105X, 1501940106X, 1501955601X, 1501955602X, 1501955603X, 1501955604X, 1501955605X, 1502051002X, 1502051004X, 1502051006X, 1502134606X, 1502134701X, 1502134703X, 1502134705X, 1502176206X, 1502326701X, 1502326702X, 1502384602X, 1502384603X, 1502384605X, 1502384606X, 1502384705X, 1502384706X, 1502443501X, 1502443503X, 1502443504X, 1502443506X, 1502459501X, 1502459502X, 1502459601X, 1502459603X, 1502459604X, 1502473801X, 1502473802X, 1502473803X, 1502473804X,  1502473805X, 1502473806X, 1502473904X, 1502473905X, 1502499501X, 1502499504X, 1502499505X.1502499506X, 1502499704X, 1502499706X, 1502522701X, 1502522702X, 1502522801X, 1502522803X, 1502568201X, 1502568202X, 1502568203X, 1502568204X, 1502568301X, 1502568302X, 1502568303X, 1502568304X, 1502568305X, 1502568306X, 1502594901X, 1502594902X, 1502594905X, 1502609201X, 1502609202X, 1502609203X, 1502609301X, 1502609303X, 1502609304X, 1502609305X, 1502609306X, 1502640502X, 1502640504X, 1502640505X, 1502640506X, 1502640602X, 1502640606X, 1502672101X, 1502672106X, 1502672204X, 1502672205X, 1502672206X, 1502695602X, 1502695604X, 1502695704X, 1502695705X, 1502733402X, 1502733403X, 1502733404X, 1502733504X, 1502733506X, 1502771903X, 1502771906X, 1502772002X, 1502772003X, 1502772006X, 1502782102X, 1502782103X, 1502782104X, 1502782105X, 1502782106X, 1502782201X, 1502782202X, 1502782205X, 1502782206X, 1502834802X, 1502834803X, 1502834804X, 1502834805X, 1502834901X, 1502834905X, 1502834906X, 1502857506X, 1502857601X, 1502857602X, 1502857603X, 1502913001X, 1502913002X, 1502913003X, 1502913004X, 1502913005X, 1502913006X, 1502913101X, 1502913103X, 1502913105X, 1502958103X, 1502958104X, 1502958105X, 1502958106X, 1502958301X, 1502958303X, 1502958306X, 1502985702X, 1502985703X, 1502985704X, 1502985706X, 1502985801X, 1502985803X, 1502985804X, 1502985805X, 1503042801X, 1503042802X, 1503090601X, 1503090602X, 1503090605X, 1503143001X, 1503143002X, 1503143004X, 1503143101X, 1503143102X, 1503175402X, 1503175404X, 1503175501X, 1503175506X, 1503218802X, 1503218803X, 1503218804X, 1503218806X, 1503218901X, 1503218905X, 1503261504X, 1503261505X, 1503261604X, 1503261605X, 1503316001X, 1503316002X, 1503316003X, 1503316102X, 1503316106X, 1503372606X, 1503402202X, 1503402302X, 1503402303X, 1503402304X, 1503402305X, 1503402306X, 1503436204X, 1503436205X, 1503436301X, 1503436302X, 1503436303X, 1503436305X, 1503436306X, 1503544602X, 1503545005X, 1503581101X, 1503581102X, 1503581204X, 1503822001X, 1503822002X, 1503822003X, 1503822101X, 1503822105X, 1503822106X, 1504063501X, 1504063503X, 1504063505X, 1504063601X, 1504063602X, 1504063603X, 1504063606X, 1504108101X, 1504108103X, 1504108104X, 1504108105X, 1504108106X, 1504108601X, 1601025103X, 1601093502X, 1601093503X, 1601093504X, 1601093505X, 1601093506X, 1601093704X, 1601135701X, 1601135702X, 1601135703X, 1601135705X, 1601135706X, 1601749301X, 1601749303X, 1601749304X, 1601749305X, 1601749306X, 1601749401X, 1601749404X, 1601749405X, 1601749406X, 1601818403X, 1601818404X, 1601818405X, 1601818406X, 1601818504X, 1601818505X, 1602059202X, 1602059203X, 1602059204X, 1602059206X, 1602059301X, 1602059304X, 1602152403X, 1602152404X, 1602152405X, 1602152406X, 1602152601X, 1602152602X, 1602152605X, 1602152606X, 1602327203X, 1602327204X, 1602327301X, 1602327302X, 1602327303X, 1602327304X, 1602487902X, 1602487905X, 1602647702X, 1602647703X, 1602647706X, 1602647801X, 1602647802X, 1602647803X, 1602750701X, 1602750704X, 1602750705X, 1602750706X, 1602750801X, 1602750802X, 1602750804X, 1602890901X, 1602890902X, 1603141405X, 1603141406X, 1603141504X, 1603141505X, 1603364801X, 1603364802X, 1603364806X, 1603364902X, 1603364903X, 1603364906X, 1603479703X, 1603479704X, 1603479801X, 1603479802X, 1603701601X, 1603762804X, 1603762805X, 1603762806X, 1603831005X, 1603831006X, 1603831101X, 1603831102X, 1603831104X, 1603875403X, 1603875406X, 1603875502X, 1603875504X, 1603875506X, 1604011304X, 1604011403X, 1604011405X, 1604115302X, 1604115304X, 1604115305X, 1604115403X, 1604115404X, 1604115405X, 1604115406X, 1604329801X, 1604329803X, 1604374601X, 1604374602X, 1604374603X, 1604374604X, 1604374605X, 1604374606X, 1701000401X, 1701000402X, 1701000403X, 1701042103X, 1701042105X, 1701042106X, 1701079602X, 1701079603X, 1701079604X;   International Serial Numbers: 1503175502X, 1501731606X, 1501898906X, 1501899002X, 1502176303X, 1502695606X, 1602059306X, 1602152401X, 1403484606X, 1403862202X, 1501355706X, 1501565901X, 1503261502X, 1503544603X, 1503544604X, 1403484504X, 1501273405X, 1501201706X, 1502051003X, 1602890805X, 1602890806X, 1503545004X.1503316006X, 1501088005X, 1501201701X, 1501201703X, 1502326706X, 1501088003X, 1501731603X, 1502672105X, 1502857503X, 1503218902X, 1503261602X, 1601749302X, 1402455303X, 1502594803X, 1502695701X, 1602750703X, 1602750803X, 1602750805X, 1602750806X, 1602890803X, 1403440405X, 1403484505X, 1502384702X, 1502443505X, 1502443805X, 1502459605X, 1502522704X, 1502522805X, 1503042701X, 1501838501X, 1501838504X, 1502176306X, 1502568205X, 1503042803X, 1503090504X, 1503090505X, 1503090603X, 1503143105X, 1503372604X, 1503372701X, 1503545002X, 1603831105X, 1502005104X, 1501672004X, 1502499502X, 1503372705X, 1602890804X, 1403990702X, 1404022205X, 1501646803X, 1502134601X, 1502640605X, 1503042704X, 1503218906X, 1503261501X, 1503261506X, 1503316004X, 1503372703X, 1604011301X, 1501273404X, 1501273406X, 1501672005X, 1502134602X, 1502640603X, 1503090604X, 1503316005X, 1503316101X, 1503436203X, 1501133005X, 1403986805X, 1501355704X, 1402959001X, 1403272703X, 1403440403X, 1403539705X, 1501088004X, 1502985701X, 1404022103X, 1501273403X, 1501274502X, 1501355601X, 1502005106X, 1502499703X, 1502499705X, 1403440401X, 1403688706X, 1501274501X, 1501274504X, 1504063502X, 1403390503X, 1403390802X, 1501672003X, 1403539604X, 1501273402X, 1502913104X, 1502985802X, 1503545001X, 1501619504X, 1501619505X, 1403272704X, 1403986602X, 1403986803X, 1501088103X, 1501201503X, 1501201505X, 1501565902X, 1501565904X, 1501940201X, 1501940203X, 1501940205X, 1501955501X, 1502050905X, 1502176204X, 1502176302X, 1502522806X, 1502594804X, 1502985806X, 1503042706X, 1503090502X, 1503143006X, 1503143104X, 1503175401X, 1503175406X, 1503544606X, 1503822102X, 1503822103X, 1601025001X, 1501132902X, 1403862203X, 1404022101X, 1404022201X, 1404022206X, 1501030603X, 1501030604X, 1501030605X, 1501133004X, 1501201502X, 1501201504X, 1501201702X, 1501201704X, 1501355701X, 1501565906X, 1501619603X, 1501731803X, 1501838503X, 1501838505X, 1501955503X, 1501955505X, 1502005103X, 1502134603X, 1502176304X, 1502384703X, 1502443801X, 1502473901X, 1502609204X, 1502640501X, 1502640503X, 1502672203X, 1603762701X, 1603762702X, 1603762703X, 1603762704X, 1603762705X, 1603762706X, 1603762801X, 1603762802X, 1603831001X, 1501940206X, 1502640604X, 1502672102X, 1503372702X, 1503402206X, 1603141403X, 1603831003X, 1603831004X, 1602059302X, 1502733401X, 1503175403X, 1403253704X, 1603831103X, 1502459503X, 1502459504X, 1502473902X, 1502473903X, 1502499702X, 1502834903X, 1502985705X, 1503175405X, 1503175505X, 1503372602X, 1504063504X, 1504063506X, 1504063604X, 1504063605X, 1601025102X, 1601025104X, 1601025106X, 1601093703X, 1601135601X, 1601135602X, 1601135603X, 1601135605X, 1601749403X, 1601818401X, 1601818402X, 1601818501X, 1601818506X, 1502050903X, 1602152402X, 1501731802X, 1501940202X, 1502050902X, 1403484605X, 1501355703X, 1502672201X, 1503143003X, 1503261601X, 1503316104X, 1501672002X, 1501838502X, 1502771904X, 1502772004X, 1502782203X, 1603875402X, 1602152603X, 1602152604X, 1501273401X, 1501899001X, 1502857606X, 1403736405X, 1501132904X, 1502594805X, 1503042804X, 1503090503X, 1503090606X, 1503544605X, 1602327206X, 1602327305X, 1402887605X, 1402887606X, 1403351005X, 1403688703X, 1501158405X, 1501565903X, 1502005201X, 1502522705X, 1502568206X, 1502672104X, 1503372605X, 1503545003X, 1603701604X, 1603701605X, 1501133001X, 1502733501X, 1502771901X, 1502913106X, 1502958101X, 1603875501X, 1603875503X, 1603875505X, 1502834902X, 1403830901X, 1501646904X, 1501672001X, 1502594904X, 1502857501X, 1503042705X, 1503042805X, 1503143103X, 1503218904X, 1503436201X, 1503436202X, 1604329805X, 1604329806X, 1503402204X, 1502772005X, 1503372601X, 1503402205X, 1503545006X, 1503581103X, 1503581104X, 1503581201X, 1503581203X, 1503822104X, 1502134702X, 1502384604X, 1502384701X, 1502594801X, 1601025002X, 1604115301X, 1601093501X, 1501355705X, 1403791802X, 1403831001X, 1403831002X, 1502005202X, 1502609205X, 1502695603X, 1502695706X, 1502958305X, 1503143005X, 1503218805X, 1603831106X, 1603875401X, 1403390504X, 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1602488006X, 1602647701X, 1602647704X, 1602890801X, 1602890802X, 1602890904X, 1603141402X, 1603141404X, 1603141503X, 1603364804X, 1603364901X, 1603364905X, 1603479701X, 1603479702X, 1603479705X, 1603479706X, 1603479803X, 1603479804X, 1603479805X, 1603479806X, 1603701602X, 1603701603X, 1603701606X, 1603875404X, 1603875405X, 1604011302X, 1604011303X, 1701277501X, 1701277502X, 1403539605X, 1403539701X, 1403688704X, 1403688705X, 1403831003X, 1403986801X, 1403484503X, 1501646801X, 1502834806X, 1603141501X, 1501030402X, 1501030405X, 1503042702X, 1403253701X, 1403332306X, 1403539602X, 1501940103X, 1502005206X, 1502134605X, 1502176305X, 1502326704X, 1502050904X, 1502134704X, 1502695601X, 1503175504X, 1603831002X, 1501940204X, 1502134706X, 1502176205X, 1502326404X, 1502443802X, 1502522703X, 1502522706X, 1502609206X, 1402705202X, 1501030403X, 1S01030404X, 1501030406X, 1501088102X, 1501955504X, 1501955606X, 1502005105X, 1502051005X, 1502522804X, 1502594906X, 1503090506X, 1503218801X, 1503261603X, 1601025003X, 1601025005X
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide and Puerto Rico): Units were also distributed globally to the following countries: Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Herzegovina, Bulgaria, Canada, Chile, Columbia, Costa Rica, Croatia, Curacao, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Ecuador, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hungary, India, Italy, Jamaica, Japan, Jordan, Kazakhstan, South Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, Ukraine, United Kingdom, and Uzbekistan
  • Description du dispositif
    LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. || LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assistant Visualization. These microscopes are used for low magnification visualization during cataract, retina, and cornea surgeries
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Alcon Research, Ltd., 6201 South Fwy, Fort Worth TX 76134-2099
  • Société-mère du fabricant (2017)
  • Source
    USFDA