Class 2 Device Recall Reusable LAMINAR Flow Irrigation Sleeve and Test Chamber

• Date Initiated by Firm: March 14, 2024
• Date Posted: May 02, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1755-2024
• Recall Event ID: 94231
• 510(K)Number: K121721
• Product Classification: Unit, phacofragmentation - Product Code HQC
• Product: 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.
• Code Information: Part Number: OPOHF21L UDI-DI/GTIN code: 05050474573376 Lot Numbers: 60477723 60479361 60505085 60508179 60508923
• FEI Number: 3012236936
• Recalling Firm/ Manufacturer: Johnson & Johnson Surgical Vision, Inc.; 31 Technology Dr Ste 200; Irvine CA 92618-2302
• For Additional Information Contact: Lori Tierney,; 904-443-3516
• Manufacturer 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.
• FDA Determined 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 intraoperative delay in surgery or even rescheduling of surgery in case there are no back up phacoemulsification sleeves available in the surgical site. Customers are instructed to: 1. Identify if any of their inventory contains Irrigation Sleeves with any of the five lot numbers. 2. Remove and Do Not Use affected Irrigation Sleeves from your inventory, regardless of whether the Irrigation Sleeves visually appear acceptable. No other Irrigation Sleeves are affected by this recall and can continue to be used. If you have product to be returned: " Complete the Customer Reply Form, noting the lot numbers of the Irrigation Sleeves. " Contact Customer Support at 1-877-266-4543 Option 2 to obtain an RGA number and arrange the product return. " Email Customer Reply Form to RegCompliOne@its.jnj.com within 3 business days of receipt of this letter. " Return the affected product as soon as possible. A credit will be issued upon receipt of the customer reply form and product. If you do not have product to be returned: " Complete and return the Customer Reply Form and email to RegCompliOne@its.jnj.com within 3 business days of receipt of this letter. For questions or concerns, contact 1-877-266-4543 Option 2.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HQC