Recall Z-3081-2017— Alcon Research, Ltd.
Class II · Terminated
Class II FDA medical device recall by Alcon Research, Ltd., initiated 2017-05-25, terminated 2022-02-04. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Alcon Research, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-25
- Terminated
- 2022-02-04
- Firm location
- Fort Worth, TX, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.