# FDA recall Z-0304-2026

> **Alcon Research LLC** · Class II · device recall initiated 2025-08-05.

## Product

Brand Name: Alcon Laboratories, Inc.  Product Name: Accessory devices for Unity and Constellation surgical consoles  Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'  8065000250	UNITY 27+DS HYPERVIT 30K VIT PROBE  8065753168	UNITY 25+ 7.5K ANTERIOR VIT PROBE  8065753179	UNITY 25+ HYPERVIT 30K VIT PROBE  Software Version: N/A  Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.  Component: N/A

## Reason for recall

Due to incomplete seals in the pouch which provide the sterile barrier.

## Distribution

Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC,SD,TN, TX, VA, WA, WI,  and WV; and OUS (foreign) to countries of: Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil,  Brunei, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Kosovo, Luxembourg, Malaysia, Mexico, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom,

## Key facts

- **Recall number:** Z-0304-2026
- **Recalling firm:** Alcon Research LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-05
- **Report date:** 2025-11-05

- **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-0304-2026

## Citation

> AI Analytics. FDA recall Z-0304-2026. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-0304-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*