{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217507", "product_res_number": "Z-0939-2026", "event_date_initiated": "2025-11-24", "event_date_posted": "2025-12-23", "recall_status": "Open, Classified", "res_event_number": "98055", "product_code": "LRO", "product_description": "Brand Name: Alcon Laboratories, Inc.\nProduct Name: Custom Pak\nModel/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10\n\nSoftware Version: N/A\nProduct Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure.\nComponent: N/A", "code_info": "UDI: *+H5301ALCON1CPAK10B*\n/9903-20 - Lot #17PJ9X,\n17188-04 - Lot # 17PJAY,\n19762-03 - Lot # 17PU09,\n19203-04- Lot # 17PMWE,\n19203-04 - Lot # 17PTXP,\n17957-10- Lot #17PTXY", "firm_fei_number": "1610287", "recalling_firm": "Alcon Research LLC", "address_1": "6201 South Fwy", "city": "Fort Worth", "state": "TX", "postal_code": "76134-2099", "additional_info_contact": "Dale Schaper\n1-817-5686421", "reason_for_recall": "Ophthalmic procedure packs may have incomplete seals affecting sterility.", "root_cause_description": "Packaging", "action": "On November 24, 2025, Alcon issued a Urgent Medical Device Notification to affected consignees. Alcon ask affected consignees to take the following actions: \n\n1. Review your inventory to determine if you have any unused affected product within your facility. \n\n2. Segregate and dispose of any unused affected product from your inventory.\n\n3. Call Alcon Customer Service to arrange for replacement of your affected inventory of Alcon Custom Pak.\n\n4. Respond to Alcon indicating your understanding of these instructions. \n\n5. Please forward this notification to all departments within your organization who may be in possession of this affected product; and any other organization to which this product may have been transferred.", "product_quantity": "151 units", "distribution_pattern": "US Nationwide distribution in the states of CA, ND, UT.", "openfda": { "k_number": [ "K882684", "K936117", "K964921", "K872448", "K910368", "K920267", "K931820", "K935686", "K874760", "K842648", "K965201", "K041080", "K952539", "K961683", "K971062", "K903336", "K913136", "K951149", "K854095", "K935743", "K925216", "K962826", "K925016", "K920292", "K963715", "K905004", "K933137", "K944044", "K901856", "K893814", "K923600", "K925467", "K961863", "K871437", "K023276", "K872011", "K924468", "K971061", "K890570", "K950574", "K930270", "K914935", "K902887", "K963443", "K871459", "K945831", "K931824", "K880942", "K945481", "K964011", "K934028", "K931760", "K902293", "K871322", "K930700", "K890726", "K892389", "K873973", "K970286", 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