{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "49677", "product_res_number": "Z-0348-2007", "event_date_initiated": "2006-09-15", "event_date_posted": "2007-03-01", "recall_status": "Terminated", "event_date_terminated": "2010-02-17", "res_event_number": "36711", "product_code": "LPN", "product_description": "Lens Plus Ocupure Saline Sterile Rinsing Solution (Asia Pacific markets, excluding Japan) & Consept Rinsing Solution\n (Japan only)", "code_info": "No US distribution", "firm_fei_number": "3003843509", "recalling_firm": "Advanced Medical Optics, Inc.", "address_1": "1700 E Saint Andrew Pl", "city": "Santa Ana", "state": "CA", "postal_code": "92705-4933", "additional_info_contact": "Sandra F. Selvaggi\n714-247-8656", "reason_for_recall": "Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility.\nBecause of this production-line issue at the firm''s plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.", "root_cause_description": "Other", "action": "Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall. \nLetters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006.", "product_quantity": "182,678 units for all US products, 2,943,207 units worldwide", "distribution_pattern": "Worldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.", "openfda": { "k_number": [ "K031193", "K863846", "K881987", "K001539", "K973921", "K030910", "K914483", "K221263", "K093254", "K033608", "K981561", "K973217", "K980775", "K864157", "K874364", "K984383", "K003031", "K132216", "K102860", "K161819", "K870278", "K982168", "K102165", "K010559", "K000998", "K130734", "K002319", "K003345", "K984573", "K051104", "K193441", "K014202", "K980133", "K880688", "K001214", "K000164", "K030278", "K992028", "K042562", "K864502", "K983225", "K093367", "K031957", "K002589", "K031521", "K031522", "K973332", "K042176", "K873548", "K062332", "K843511", "K974624", "K030092", "K871714", "K083812", "K151768", "K041008", "K981574", "K071203", "K112909", "K050250", "K923438", "K990480", "K863346", "K981151", "K872973", "K222541", "K021143", "K982775", "K070767", "K190674", "K030522", "K021635", "K191872", "K890303", "K980591", "K003252", "K191795", "K974485", "K991620", "K011796", "K060924", "K980147", "K974625", "K852386", "K983780", "K013479", "K071236", "K210051", "K050517", "K111877", "K162597", "K050729", "K012731", "K991403", "K974723", "K200747", "K142284", "K202932", "K984575", "K923437", "K031646", "K003109", "K031753", "K983973", "K161622", "K991125", "K000247", "K990422", "K013512", "K032030", "K872164", "K110221", "K032481", "K011561", "K981168", "K170483", "K990044", "K983150", "K002823" ], "pma_number": [ "P850070", "N18073", "P850075", "P860050", "P840069", "P820087", "P880056", "P870051", "P870007", "P860033", "P890054", "P840066", "N17908", "P850093", "P810017", "P800028", "N16993", "P800034", "P790001", "P870002", "N17654", "P810047", "P820040", "P810041", "P810009", "P830071", "P800055", "P870026", "P860060", "P870017", "P890059", "P880052", "P850025", "P850037", "P830013", "P860066", "P860023", "P850076", "P860061", "P810008", "P790023", "P810039", "P820053", "P800065", "P810030", "P800060", "P900029", "P850047", "P870058", "P880080", "P910075", "N17786", "P820001", "P910074", "P810029", "N17974", "P840020", "P820070", "P850065", "P820050", "P880053", "P880079", "P870037", "P830023", "P800018", "P820069", "P810015", "P800026", "P850012", "P850026", "P800038", "N18078", "P890067", "P900047", "P820036", "P850055", "P790029", "P800069", "P870029", "N17945", "P820031", "P810034", "N18020", "P830009", "P870005", "P890062", "N18143", "P790024", "P790011", "P960012", "P850088", "P830034", "P870023", "P800001", "P850036", "P850045", "P870050", "P800024" ], "registration_number": [ "3006140792", "3011771819", "9614761", "3003093882", "3005010990", "1313525", "3008789244", "2335740", "3004270595", "9681630", "3011714173", "9617489", "3007392179", "3010200303", "1643525", "1937310", "2249258", "8020862", "3009446098", "3004178847", "1719513", "3012236936", "3006195167", "3010607087", "2522206", "3003485793", "2011068", "3003515967", "1610287", "3003306559", "3003062331", "1032500", "2026940" ], "fei_number": [ "3006140792", "3011771819", "3003093882", "3005010990", "1000119582", "3008789244", "1000188353", "3002806285", "3004270595", "3011714173", "3003598505", "3007392179", "1643525", "1937310", "3009446098", "1317628", "3006974616", "3004178847", "1719513", "3012236936", "3006195167", "3010607087", "2522206", "3003485793", "2011068", "3003515967", "1610287", "3003306559", "3003062331", "3002224304", "1032500", "2026940", "3002808845" ], "device_name": "Accessories, Soft Lens Products", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.5928", "device_class": "2" } } ] }