Z-3081-2017Class II

LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope...

Name: Z-3081-2017 LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope...
Creator: Alcon Research, Ltd.
Published: 2017-05-25
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2017-05-25 / Terminated / root cause: packaging

FDA source

Alcon Research, Ltd. began a recall of LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but... on 2017-05-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3081-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-25
Posted: 2017-08-28
Terminated: 2022-02-04
Recalling firm: Alcon Laboratories
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
Product code: HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
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.
Root cause tag: packaging
FDA root cause: 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
Product codes and lots: 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, 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3081-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3081-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-28

Product code HRM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)