{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "218617", "product_res_number": "Z-1634-2026", "event_date_initiated": "2026-02-19", "event_date_posted": "2026-03-24", "recall_status": "Open, Classified", "res_event_number": "98402", "product_code": "HQL", "pma_numbers": [ "P980040", "P980040S117" ], "product_description": "Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity\" Delivery System\nProduct Name: TECNIS Eyhance IOL with TECNIS Simplicity\" Delivery System\nModel/Catalog Number: DIB00\nSoftware Version: N/A\nProduct Description: The TECNIS SIMPLICITY\" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY\" Delivery System Model DIB00 contains the TECNISEyhance\" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY\" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye.\nComponent: No", "code_info": "Lot Code: GTIN: 05050474731776\nSKU: DIB00U0210-12\nSerial Numbers:\n2409342403\n2410072403\n2409612403\n2409692403\n2409752403\n2891682403\n2891132403\n2892032403\n2531882403\n2531902403\n2531212403\n2530842403\n2531242403\n2531892403\n2531622403", "firm_fei_number": "2648035", "recalling_firm": "AMO Puerto Rico Manufacturing, Inc.", "address_1": "Rd # 402 North Km 4.2, Industrial Park Rd # 402 North Km 4.2 Industrial Park", "city": "Anasco", "postal_code": "00610", "country": "PR", "reason_for_recall": "Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.", "root_cause_description": "Process control", "action": "On 02/19/2026, the firm send via FedEx an \"URGENT: MEDICAL DEVICE RECALL\" Letter to customers informing them that in a limited quantity of TECNIS Eyhance IOL (intraocular lens) with TECNIS Simplicity\" Delivery System (DIB00) products exhibit an occurrence of haptics sticking to the optic, which can prevent the lens from unfolding as expected following lens insertion during the surgical procedure.\n\nCustomers are instructed to:\n1. Identify if any inventory contains TECNIS Eyhance IOL (intraocular lens) with TECNIS Simplicity\" Delivery System (DIB00).\n2. Do not use and remove all affected TECNIS Eyhance IOL (intraocular lens) with TECNIS Simplicity\" Delivery System (DIB00) from inventory.\n3. Complete Customer Reply Form. It is required information for reconciliation purposes with regulatory agencies, even if you have no inventory.\nFor products to be returned:\n\" Complete the Customer Reply Form, noting the serial number of the TECNIS Eyhance IOL (intraocular lens) with TECNIS Simplicity\" Delivery System (DIB00).\n\" Use the provided return label or contact the Global Post Market Safety Team at 1-877-266-4543, Option 2 to obtain an RGA number and arrange product return.\n\" Email Customer Reply Form to JJV-US-ProductExperience@its.jnj.com within 3 business days of receipt of this letter.\n\" If issues were encountered, inform JJSV by calling the Global Post Market Safety Team 1-877-266-4543, Option 2 or send an email to JJV-US-ProductExperience@its.jnj.com . If reporting a complaint, provide the serial number, the date of surgery, a description of the event, and patient outcome.\n\" Return affected product as soon as possible. The firm will work directly with customers to replace the affected unit and provide any necessary next steps.\nIf you do not have product to be returned:\n\" Review your patient records to confirm implantation of the impacted lens. No further action is required after the Customer Reply Form has been returned.", "product_quantity": "361", "distribution_pattern": "U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI.", "openfda": { "k_number": [ "K913626", "K842892", "K842504", "K914311", "K771933" ], "pma_number": [ "P860034", "P880090", "P880087", "P840060", "P800017", "P910061", "P040020", "P910058", "P980040", "P100016", "P820035", "P880091", "P240038", "P880010", "P820016", "P840039", "P930014", "P820049", "P840033", "P880085", "P090022", "P890068", "P840050", "P790027", "P810055", "P880082", "P800016", "P080004", "P870045", "P810018", "P910056", "P870075", "P870013", "P970034", "P820044", "P990013", "P830056", "P860059", "P800049", "P850059", "P900037", "P810042", "P900048", "P190018", "P810056", "P830033", "P880072", "P960036", "P060011", "P080021", "P810001", "P800027", "P910060", "P010027", "P060022", "P880070", "P990014", "P830040", "P820072", "P900053", "P960034", "P880081", "P860002", "P990080", "P890056", "P870073", "P940007", "P810032" ], "registration_number": [ "3012236936", "1054811", "9710098", "3024715547", "9612169", "3010126268", "3006946276", "1037089", "1064514", "2032098", "3002807314", "2953359", "3007125265", "2020277", "2031474", "1610287", "3014002883", "3003304724", "3008344633", "2023826", "1119279", "1119421", "9613160", "3013202565", "9614429", "2031959", "1048735", "2029275", "3008641313", "1211998", "2246552", "1313525", "9614546", "3007207818", "3017435679", "1281950", "2529709", "3017636737", "3010413216", "3015456951", "9681630", "2030624", "3020977988", "2648035", "9681121", "3006723646", "3012304651", "3008449456", "1038833", "3007530141", "1063199", "3010155661", "2011171", "3010148516", "2031928", "2438659", "3014173684" ], "fei_number": [ "3012236936", "3002808259", "3024715547", "3002957101", "3010126268", "3006946276", "1037089", "3002807314", "3002808262", "3000206435", "3007125265", "3001284430", "2020277", "3002808845", "1610287", "3003088462", "3003058448", "3014002883", "3003304724", "3008344633", "2023826", "1119279", "1119421", "3013202565", "3004161528", "1048735", "3008641313", "1211998", "2246552", "3002023310", "3002807944", "3007207818", "3017435679", "1281950", "3002936283", "3017636737", "3001659659", "3010413216", "3015456951", "1000114185", "3020977988", "2648035", "1000306431", "3006723646", "3012304651", "3000215205", "1317628", "3008449456", "1038833", "3007530141", "3004651700", "3010155661", "2011171", "3010148516", "1000121259", "3014173684", "3002777043" ], "device_name": "Intraocular Lens", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.3600", "device_class": "3" } } ] }