{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 74 } }, "results": [ { "cfres_id": "196039", "product_res_number": "Z-0086-2023", "event_date_initiated": "2022-09-01", "event_date_posted": "2022-10-12", "recall_status": "Open, Classified", "res_event_number": "90847", "product_code": "HQC", "k_numbers": [ "K203060" ], "product_description": "Veritas Advanced Infusion Packs. Used in ophthalmic procedures.", "code_info": "Part Number: VRT-AI\nUDI-DI Code: 05050474700901\nLot Numbers:\n60316112\n60330206\n60330248\n60341105\n60341106\n60341107\n60342401\n60343412\n60343413\n60351691\n60352993\n60352994\n60352995\n60352996\n60352997\n60352998\n60352999\n60353436\n60353443\n60353444\n60353445\n60353446\n60353447\n60353448\n60353449\n60353450\n60353451\n60353452\n60353453\n60353772\n60353811\n60353812\n60353813\n60353814\n60353815\n60354982\n60355023\n60355024\n60355025\n60355026\n60355027\n60355330\n60355335\n60355972\n60360065\n60360066\n60362043\n60362044\n60362435\n60362436\n60364566\n60369607\n60369608\n60369609\n60381689", "firm_fei_number": "3012236936", "recalling_firm": "Johnson & Johnson Surgical Vision, Inc.", "address_1": "31 Technology Dr Ste 200 31 Technology Dr", "address_2": "Ste 200", "city": "Irvine", "state": "CA", "postal_code": "92618-2302", "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.", "root_cause_description": "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.\n\nCustomers are required to:\n1.Identify if any of their inventory contains VERITAS Packs with a lot number listed on page 5.\n2.Immediately discontinue using and remove from their inventory all affected VERITAS Packs. No other VERITAS Advanced Infusion Packs are affected by this recall.\n3.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.\n\nIf customers have product to be returned:\n-Complete the Customer Reply Form, noting the lot numbers of the VERITAS Packs.\n-Contact Customer Support at 1-877-266-4543 Option 2 to obtain a RGA number and arrange the product return.\n-Email Customer Reply Form to RegCompliOne@its.jnj.com within 3 business days of receipt of this letter.\n- A credit will be issued upon receipt of the customer reply form and product.\nIf you do not have product to be returned: Email Customer Reply Form to RegCompliOne@its.jnj.com \n\nFor questions or concerns, contact 1-877-266-4543 Option 2.", "product_quantity": "53,624 units", "distribution_pattern": "Worldwide Distribution. 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"medical_specialty_description": "Ophthalmic", "regulation_number": "886.4670", "device_class": "2" } } ] }