# FDA recall Z-0961-2019

> **Alcon Research Laboratories Ltd.** · Class II · device recall initiated 2018-07-17.

## 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

- **Recall number:** Z-0961-2019
- **Recalling firm:** Alcon Research Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0961-2019. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0961-2019. Source: US FDA. Licensed CC0.

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