LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 M...
FDA Device Recall #Z-3081-2017 — Class II — May 25, 2017
Recall Summary
| Recall Number | Z-3081-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 25, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Alcon Research, Ltd. |
| Location | Fort Worth, TX |
| Product Type | Devices |
| Quantity | 1,074 units |
Product 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 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.
Distribution Pattern
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
Lot / 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
Other Recalls from Alcon Research, Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2408-2023 | Class II | Infinity FMS Pak | Jun 28, 2023 |
| Z-2407-2023 | Class II | Centurion FMS Pak | Jun 28, 2023 |
| Z-2406-2023 | Class II | Constellation Procedure Pak | Jun 28, 2023 |
| Z-2410-2023 | Class II | Phaco Standalone Tips | Jun 28, 2023 |
| Z-2411-2023 | Class II | Alcon Custom Pak | Jun 28, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.