The Recall Desk
HighFDA (Devices)·Z-3081-2017·Announced 2017-09-06

Alcon Recalls LuxOR Ophthalmic Microscope Floor Stands Due to Caster Defect

Alcon is recalling 1,074 LuxOR microscope floor stands because casters may break or detach from the base after impact or stress.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural component (caster) that could break or detach, posing a risk of harm in a surgical setting, although no injuries have been reported.

Plain-English summary

Alcon Research, Ltd. is recalling 1,074 units of the LX3 Floor Stand for LuxOR Ophthalmic Microscope and the Endure LuxOR Q-VUE Ophthalmic Microscope. These floor stands are used in combination with LuxOR ophthalmic microscopes for low magnification visualization during cataract, retina, and cornea surgeries. The affected units were distributed worldwide, including the United States, Puerto Rico, and numerous international countries.

The recall was initiated because multiple shipments or forceful impact to a caster on the LuxOR/LX3 microscope may stress the microscope base. This stress could contribute to a caster breaking or detaching from the base. The source text does not report any injuries or illnesses associated with this defect.

Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. Alcon Research, Ltd. is the recalling firm and is responsible for managing the recall process for these devices.

The recalled product

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 Assista
Manufacturer
Alcon Research, Ltd.
Category
Medical Device — Ophthalmic Microscope Accessories
Hazard
Affected units
1,074

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Domestic Serial Numbers: 1402548501X
  • 1402548502X
  • 1402548503X
  • 1402548504X
  • 1402548505X
  • 1402548506X
  • 1402577401X
  • 1402577402X
  • 1402577403X
  • 1402577404X
  • 1402577405X
  • 1402577406X
  • 1402612001X
  • 1402612002X
  • 1402612003X
  • 1402612004X
  • 1402612005X
  • 1402612006X
  • 1402655703X
  • 1402655704X

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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