Class 2 Device Recall Veritas Advanced Infusion Packs

• Date Initiated by Firm: September 01, 2022
• Date Posted: October 12, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0086-2023
• Recall Event ID: 90847
• 510(K)Number: K203060
• Product Classification: Unit, phacofragmentation - Product Code HQC
• Product: Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
• Code Information: Part Number: VRT-AI UDI-DI Code: 05050474700901 Lot Numbers: 60316112 60330206 60330248 60341105 60341106 60341107 60342401 60343412 60343413 60351691 60352993 60352994 60352995 60352996 60352997 60352998 60352999 60353436 60353443 60353444 60353445 60353446 60353447 60353448 60353449 60353450 60353451 60353452 60353453 60353772 60353811 60353812 60353813 60353814 60353815 60354982 60355023 60355024 60355025 60355026 60355027 60355330 60355335 60355972 60360065 60360066 60362043 60362044 60362435 60362436 60364566 60369607 60369608 60369609 60381689
• Recalling Firm/ Manufacturer: Johnson & Johnson Surgical Vision, Inc.; 31 Technology Dr Ste 200; Irvine CA 92618-2302
• Manufacturer Reason for Recall: As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.
• FDA Determined Cause: Under Investigation by firm
• Action: On 09/01-02/2022, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via UPS 2-Day Mail to customers informing them that the firm is recalling specific lots of VERITAS Advanced Infusion Packs due to the potential for the irrigation luer to crack or break which could lead to reduced irrigation pressure during surgery, associated with an unstable anterior chamber. Customers are required to: 1.Identify if any of their inventory contains VERITAS Packs with a lot number listed on page 5. 2.Immediately discontinue using and remove from their inventory all affected VERITAS Packs. No other VERITAS Advanced Infusion Packs are affected by this recall. 3.Complete the attached Customer Reply Form (on page 4). We require this information for reconciliation purposes with regulatory agencies, even if you have no inventory. If customers have product to be returned: -Complete the Customer Reply Form, noting the lot numbers of the VERITAS Packs. -Contact Customer Support at 1-877-266-4543 Option 2 to obtain a 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. - A credit will be issued upon receipt of the customer reply form and product. If you do not have product to be returned: Email Customer Reply Form to RegCompliOne@its.jnj.com For questions or concerns, contact 1-877-266-4543 Option 2.
• Quantity in Commerce: 53,624 units
• Distribution: Worldwide Distribution. US states of AL, AR, AZ, CA, CO, DE, FL, GA, HI, IL IN, KY LA, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, VA, and WA; Australia, Azerbaijan, Belgium, Brazil, Canada, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Ireland, Italy, Japan, Jordan, Kuwait, Morocco, Netherlands, New Zealand, Oman, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom
• 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 and Original Applicant = Johnson & Johnson Surgical Vision, Inc.