Alcon Ophthalmic Microscope Recalled for Potential Optical Head Detachment
Alcon is recalling LuxOr E71 and E71 Q-Vue ophthalmic microscopes because the optical head may detach from the stand due to missing thread adhesive.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a risk-of-harm product (medical device) where a mechanical failure could lead to injury, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Alcon Research Laboratories Ltd. is recalling specific models of the LuxOr E71 and E71 Q-Vue ophthalmic microscopes. These devices are used for low magnification visualization during ophthalmic surgical procedures for cataract, retina, and cornea. The recall involves 544 units, with 399 distributed to the United States and the remainder distributed worldwide.
The recall is being conducted because the optical head has the potential to detach from the stand due to the lack of thread adhesive. This defect could compromise the stability of the microscope during use. The affected units were distributed to various states in the US, including AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, Puerto Rico, and the US Virgin Islands, as well as numerous international locations.
Healthcare facilities and users should identify affected units by checking the model numbers and serial numbers listed in the official recall notice. If a unit is found to be affected, it should be removed from service and returned to Alcon for repair or replacement according to the company's instructions.
The recalled product
- Product
- Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
- Manufacturer
- Alcon Research Laboratories Ltd.
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)
- Model: LuxOr E71 and E71 Q-Vue 8065752304
- 8065752323
- 8065752332
- and 8065752333 US Serial numbers: 22013
- 1401148103X
- 1401148201X
- 1401148204X
- 1401554606X
- 1401845004X
- 1401845005X
- 1401974102X
- 1401974104X
- 1401974105X
- 1401977002X
- 1401977003X
- 1402067603X
- 1402067604X
- 1402067605X
- 1402149501X
- 1402149503X
Distribution
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