Fort Worth, TX, United States
Alcon Research Laboratories Ltd. recalls
1 recall recorded since 2018, most recently on 17 July 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 17 July 2018
- Terminated
- 28 April 2021
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0961-2019
- Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.