Alcon Ophthalmic Microscope Recalled for Potential Optical Head Detachment

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.

Category

Medical Device — Ophthalmic Surgical Equipment

Hazard

• mechanical-failure
• falling-object

Is your product affected?

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

Distribution

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