# FDA recall Z-1755-2024

> **Johnson & Johnson Surgical Vision, Inc.** · Class II · device recall initiated 2024-03-14.

## Product

Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber   21 Gauge REF OPOHF21L    The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.

## Reason for recall

Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause  possible harms.

## Distribution

U.S. Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, LA, MA, MD, ME, MN, MO, NC, NJ, NY, OR, PA, SC, TX, VA, WA, and WI.

## Key facts

- **Recall number:** Z-1755-2024
- **Recalling firm:** Johnson & Johnson Surgical Vision, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-14
- **Report date:** 2024-05-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1755-2024

## Citation

> AI Analytics. FDA recall Z-1755-2024. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1755-2024. Source: US FDA. Licensed CC0.

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