Recall Z-3081-2017 ยท HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Alcon Research, Ltd.
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 sur
| Date | May 25, 2017 |
| Status | Terminated |
| Reason | 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 | 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 | 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, Dom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.