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.

Recall Insight

This FDA Devices action (record #Z-1755-2024) was formally reported on May 8, 2024, with the manufacturer initiating the action on March 14, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Johnson & Johnson Surgical Vision, Inc. is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 3,428 units.

The documented reason for this recall is: 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 unsta… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.