FDA recall Z-3081-2017

Alcon Research, Ltd. · Class II · device

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

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

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

Key facts

Status
Terminated
Initiation date
2017-05-25
Report date
2017-09-06
Termination date
2022-02-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fort Worth, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3081-2017