# FDA recall Z-1033-2022

> **Johnson & Johnson Surgical Vision Inc** · Class II · device recall initiated 2022-04-06.

## Product

TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,

## Reason for recall

Potential breach in the sterility barrier for tray ring covers.

## Distribution

Worlwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, 	HI, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, WA, WI and the countries of Chile, Indonesia, India, Japan, Malaysia, Philippines, Taiwan.

## Key facts

- **Recall number:** Z-1033-2022
- **Recalling firm:** Johnson & Johnson Surgical Vision Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-06
- **Report date:** 2022-05-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Ana, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1033-2022

## Citation

> AI Analytics. FDA recall Z-1033-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1033-2022. Source: US FDA. Licensed CC0.

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