FDA recall Z-0961-2019

Alcon Research Laboratories Ltd. · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-07-17
Report date
2019-03-06
Termination date
2021-04-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fort Worth, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0961-2019