Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve Recalled by Johnson & Johnson Surgical Vision, Inc. Due to Due to a manufacturing variation of the irrigation...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Johnson & Johnson Surgical Vision, Inc. directly.
Affected Products
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.
Quantity: 3,428 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Johnson & Johnson Surgical Vision, Inc.
Johnson & Johnson Surgical Vision, Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report