Alcon Research Laboratories Ltd. recalls Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgica…

Recall date

July 17, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0961-2019

FDA classification

Class II

Brand / firm

Alcon Research Laboratories Ltd.

Sold / distributed

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…

Why it was recalled

Potential for the optical head to detach from the stand due to the lack of thread adhesive.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.