Johnson & Johnson Surgical Vision, Inc. Recall 94231
Description: 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.
Johnson & Johnson Surgical Vision, Inc. Recall 94231 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1755-2024 |
| Event ID | 94231 |
| Event Description | 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. |
| Product Type | Devices |
| 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 |
| Recall Reason | 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. |
| Device Classification | 20240508 |
| Device Code Info | Part Number: OPOHF21L UDI-DI/GTIN code: 05050474573376 Lot Numbers: 60477723 60479361 60505085 60508179 60508923 |
| Center Classification Date | 20240502 |
| Recall Initiation Date | 20240314 |
| Recalling Firm | Johnson & Johnson Surgical Vision, Inc. |
| Initial Notification | Letter |
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