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FDAFDA · Food and drugs·Recall number Z-3081-2017

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

Published September 6, 2017 · Recall initiated: May 25, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Alcon Research, Ltd.
Distributor
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
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,
Risk classification
Class II
Area (FDA)
device
Country
United States

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