{ "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": 1 } }, "results": [ { "cfres_id": "94408", "product_res_number": "Z-0129-2011", "event_date_initiated": "2010-07-23", "event_date_posted": "2010-11-02", "recall_status": "Terminated", "event_date_terminated": "2011-10-13", "res_event_number": "56735", "product_code": "LPN", "k_numbers": [ "K014202" ], "product_description": "AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). \n\nCleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.", "code_info": "Lot Numbers: AH01202, AH01072, AH01223, AH01224, and AH01225.", "firm_fei_number": "3003843509", "recalling_firm": "Abbott Medical Optics Inc (AMO)", "address_1": "1700 E Saint Andrew Pl", "city": "Santa Ana", "state": "CA", "postal_code": "92705", "additional_info_contact": "714-247-8656", "reason_for_recall": "The recall was initiated after AMO determined, through internal testing, that a limited number of the flip top caps used during production of these solutions may leak and, although unlikely, the sterility of the product may be compromised. Products that are non-sterile have the potential to cause eye infections, which may be sight threatening.", "root_cause_description": "Pending", "action": "AMO prepared and issued on July 28, 2010 both a customer and distributor notification letter as part of their customer communication process. The letter informed the customers of the reason for recall, the products involved, the hazard involved and actions to be taken regarding the affected products.\n\nCustomer with questions related to the COMPLETE Multi-Purpose Solution and/or Total Care (1) Contact Lens Solution return process, were instructed to contact an AMO Customer Service Representative at 1800 931 663.", "product_quantity": "34,080 units", "distribution_pattern": "International Distribution Only -- United Kingdom, Lebanon, Dubai, Bahrain, Russia, Kazakhstan, Ireland, and France.", "openfda": { "k_number": [ "K041008", "K033608", "K000998", "K980147", "K070767", "K992028", "K051104", "K031646", "K974723", "K981151", "K170483", "K102860", "K923437", "K001214", "K012731", "K983973", "K852386", "K013479", "K923438", "K870278", "K222541", "K162597", "K031521", "K042562", "K983150", "K872973", "K890303", "K111877", "K880688", "K003031", "K881987", "K060924", "K030522", "K161622", "K974485", "K112909", "K191872", "K981168", "K030278", "K000164", "K980133", "K021635", "K093254", "K093367", "K032030", "K003109", "K071203", "K990480", "K191795", "K021143", "K981574", "K990044", "K110221", "K042176", "K002589", "K011796", "K161819", "K031957", "K031753", "K991620", "K973921", "K030092", "K980591", "K843511", "K031193", "K130734", "K991125", "K873548", "K032481", "K002319", "K010559", "K011561", "K003252", "K914483", "K991403", "K974624", "K980775", "K981561", "K013512", "K984573", "K003345", "K050517", "K982775", "K871714", "K864157", "K083812", "K193441", "K202932", "K001539", "K973217", "K983780", "K102165", "K210051", "K014202", "K973332", "K200747", "K050250", "K863846", "K990422", "K030910", "K071236", "K132216", "K062332", "K000247", "K984575", "K983225", "K872164", "K002823", "K031522", "K864502", "K151768", "K190674", "K982168", "K050729", "K142284", "K221263", "K874364", "K863346", "K984383", "K974625" ], "pma_number": [ "P870026", "P800018", "P820053", "N16993", "P830009", "P810008", "N18143", "P900047", "P880079", "P850075", "P840069", "P830071", "P850025", "P860023", "P860061", "P810029", "P890062", "P850055", "P810047", "N17654", "P800069", "P880056", "P800028", "P870058", "P820070", "P880053", "P810017", "P850093", "P800038", "N17908", "P850037", "P870017", "P870050", "N18073", "P900029", "P790024", "P810009", "P820001", "P870037", "P850026", "P850045", "P870002", "P850012", "P880080", "P850076", "N18078", "P810039", "P860066", "P870051", "P820031", "P860060", "P890067", "P890059", "P850036", "P840066", "P820050", "P910075", "P790001", "P850047", "P890054", "P960012", "P870005", "P820036", "P870007", "N17786", "P800055", "P870029", "P860050", "P800060", "P810015", "P800065", "N17974", "P820040", "P850070", "P880052", "P850065", "N17945", "P790029", "P800026", "P810030", "P820069", "P840020", "P820087", "P800001", "P830023", "P810034", "P830013", "P870023", "P830034", "P800034", "P790011", "N18020", "P910074", "P850088", "P860033", "P810041", "P790023", "P800024" ], "registration_number": [ "3003306559", "3003485793", "1719513", "3011714173", "3010200303", "3006140792", "2249258", "2026940", "3004270595", "3007392179", "3012236936", "3003093882", "8020862", "3009446098", "2011068", "3010607087", "3004178847", "3006195167", "9681630", "9614761", "2335740", "1643525", "3005010990", "9617489", "3008789244", "3003062331", "3003515967", "1032500", "3011771819", "2522206", "1937310", "1313525", "1610287" ], "fei_number": [ "3003306559", "1000119582", "3003485793", "3006974616", "1719513", "3011714173", "3006140792", "3002224304", "2026940", "3004270595", "1000188353", "3007392179", "3012236936", "1317628", "3003093882", "3002808845", "3009446098", "3010607087", "3004178847", "3003598505", "3006195167", "2011068", "1643525", "3005010990", "3002806285", "3008789244", "3003062331", "3003515967", "1032500", "3011771819", "2522206", "1937310", "1610287" ], "device_name": "Accessories, Soft Lens Products", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.5928", "device_class": "2" } } ] }