{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "194413", "product_res_number": "Z-1373-2022", "event_date_initiated": "2022-06-09", "event_date_created": "2022-07-12", "recall_status": "Open, Classified", "res_event_number": "90437", "product_code": "LRO", "k_numbers": [ "K880961" ], "product_description": "Alcon Custom Pak Surgical Procedure Pack:\n16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP\n\n18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE\n\n18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS\n\n11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR\n\n11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR\n\n11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR\n\n14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS", "code_info": "Pak #/Batch # / UDI Code 16998-11 / 2519351H / (01)10380651677385(10)2519351H(17)230331(30)3 18392-03 / 14HDFF / (01)10380651665238(10)14HDFF(17)221231(30)4 18527-03 / 14JM57 / (01)10380651684406(10)14JM57(17)240630(30)5 11802-07 / 14KFAF / (01)10380653423096(10)14KFAF(17)240430(30)5 11802-07 / 14LTRW / (01)10380653423096(10)14LTRW(17)240430(30)5 11802-07 / 14LLME / (01)10380653423096(10)14LLME(17)240430(30)5 14429-07 / 14HPW3 / (01)10380651666433(10)14HPW3(17)240229(30)6", "firm_fei_number": "1000117501", "recalling_firm": "Alcon Research, LLC", "address_1": "9965 Buffalo Speedway", "city": "Houston", "state": "TX", "postal_code": "77054-1309", "additional_info_contact": "713-668-9100", "reason_for_recall": "Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.", "root_cause_description": "Process control", "action": "On 06/09/2022, the firm sent an \"URGENT: VOLUNTARY MEDICAL DEVICE REMOVAL\" Letter via overnight mail to customer informing them that specific lots of Alcon Custom Paks were manufactured containing latex gloves and were intended to contain non-latex gloves.\n\nCustomers are instructed to:\n1. Review your inventory to determine if you have any unused affected product within your facility. See Table above for affected Custom Pak.\n2. Segregate any unused affected product from your inventory.\n3. An Alcon associate will reach out to you directly to arrange for the return and replacement of your affected inventory of Alcon Custom Pak.\n4. Fill out the attached Response Form , even if you have zero (0) units remaining in inventory and return the form to Alcon using the contact information provided on the form.\n5. Please forward this information to:\n\" all departments within your organization who may be in possession of this affected product; and\n\" any other organization to which this product may have been transferred.\n\nFor questions - contact Alcon Customer Service at 1-800-862-5266", "product_quantity": "320 kits", "distribution_pattern": "U.S.: AZ, CA, MO, and NY\n\nO.U.S.: None", "openfda": { "k_number": [ "K890098", "K931844", "K890729", "K932217", "K880942", "K944044", "K930700", "K931673", "K871459", "K883250", "K914037", "K890726", "K950574", "K882684", "K914036", "K951478", "K920292", "K934688", "K952539", "K895202", "K963443", "K931760", "K041080", "K961683", "K964921", "K854095", "K871873", "K933137", "K892389", "K935740", "K934029", "K893814", "K964011", "K914174", "K872011", "K023276", "K971062", "K922133", "K890570", "K902888", "K925214", "K965201", "K941846", "K931759", "K934028", "K951149", "K932220", "K963715", "K935741", "K922648", "K932652", "K931758", "K920267", 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Surgery Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2" } } ] }