Home / Recalls / Medical Devices
Alcon Research Laboratories Ltd. recalls Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surg
Recalled March 6, 2019 · FDA recall Z-0961-2019 · Alcon Research Laboratories
Hazard
Potential for the optical head to detach from the stand due to the lack of thread adhesive. · FDA Class II
Units
544 (399 units to USA)
Sold at
Worldwide Distribution - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, Ml, 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 US Virgins Islands Australia, Austria, Bahamas, Belarus, Canada, Chile, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, Germany, Guatemala, India, Indonesia, Italy, Jamaica, Japan, Kenya, Lebanon, Mexico, Netherland Antilles, Norway, Peru, Philippines, Poland, Romania, Slovakia, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, and Vietnam
Description
Potential for the optical head to detach from the stand due to the lack of thread adhesive.
Product
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
Manufacturer(s)
Alcon Research Laboratories Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →