BEUDAMED
    FDA Enforcement Class II Terminated

    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

    Recall: Z-3081-2017 · Reported September 6, 2017

    Enforcement

    Recall Number
    Z-3081-2017
    Event ID
    77480
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Research, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 6, 2017
    Initiation Date
    May 25, 2017
    Classification Date
    August 28, 2017
    Termination Date
    February 4, 2022
    Address
    6201 South Fwy, N/A, Fort Worth, TX, 76134-2099, United States

    Description

    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

    Reason

    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.

    Code Info

    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, 1403390505X, 1403390801X, 1403736403X, 1502695703X, 1503372704X, 1503581202X, 1503822004X, 1504108102X, 1601025004X, 1602890903X, 1602890905X, 1602890906X, 1603141401X, 1701000404X, 1701042104X, 1701079601X, 1701079606X, 1701134801X, 1701134803X, 1701134806X, 1701211101X, 1701211102X, 1701211103X, 1701211104X, 1701211202X, 1701211206X, 1403791706X, 1403862301X, 1403862303X, 1403862304X, 1403211703X, 1403332301X, 1403351001X, 1403351003X, 1403351004X, 1403484506X, 1403625503X, 1403791701X, 1403791804X, 1403986802X, 1501274506X, 1501619602X, 1501646802X, 1501646805X, 1501646806X, 1501646905X, 1501672103X, 1501790101X, 1501899005X, 1501955502X, 1502005101X, 1502326406X, 1502326703X, 1502443803X, 1502459506X, 1502459606X, 1502499701X, 1502594802X, 1502733503X, 1502958304X, 1503143106X, 1503175503X, 1503261503X, 1503372603X, 1503436304X, 1503544601X, 1601749402X, 1602327202X, 1602327306X, 1602487903X, 1602488001X, 1602488002X, 1602488003X, 1602488004X, 160248800SX, 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

    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

    Quantity

    1,074 units