PlainRecalls
FDA Devices Moderate 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

Reported: September 6, 2017 Initiated: May 25, 2017 #Z-3081-2017

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.

Details

Recalling Firm
Alcon Research, Ltd.
Units Affected
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
Location
Fort Worth, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by Alcon Research, Ltd.. Units affected: 1,074 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 6, 2017. Severity: Moderate. Recall number: Z-3081-2017.