Recall Z-1755-2024 ยท HQC Unit, Phacofragmentation
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 direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.
| Date | May 2, 2024 (initiated Mar 14, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On 03/11/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx 2-Day Mail Delivery to customers informing them that due to a manufacturing issue with the Irrigation Sleeves which could result in a missing or incompletely cut port hole. A missing hole or incompletely cut port hole is visible on inspection with the naked eye and can also be functionally detected prior to surgery, if and when, the user engages the irrigation function in accordance with the Directions for Use. A completely missing port hole will result in a priming error prior to surgery. This could lead to intra |
| Quantity | 3,428 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121721 | LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) Abbott Medical Optics, Inc., Oct 15, 2012 |