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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon Lux OR LX3 Microscope Floor Stand

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  Class 2 Device Recall Alcon Lux OR LX3 Microscope Floor Stand see related information
Date Initiated by Firm May 25, 2017
Create Date August 28, 2017
Recall Status1 Terminated 3 on February 04, 2022
Recall Number Z-3081-2017
Recall Event ID 77480
Product Classification Microscope, operating & accessories, ac-powered, ophthalmic - Product Code HRM
Product 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
Code Information 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 
Recalling Firm/
Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Packaging process control
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.
Quantity in Commerce 1,074 units
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
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.