Johnson & Johnson Surgical Vision, Inc.: Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to dire

Hazard

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.

Details from the source

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. Quantity: 3,428 units Lot/code info: Part Number: OPOHF21L UDI-DI/GTIN code: 05050474573376 Lot Numbers: 60477723 60479361 60505085 60508179 60508923

UPC codes

05050474573376

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.