{ "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": "104240", "product_res_number": "Z-0275-2012", "event_date_initiated": "2011-09-20", "event_date_posted": "2011-11-23", "recall_status": "Terminated", "event_date_terminated": "2014-01-08", "res_event_number": "59980", "product_code": "HQL", "pma_numbers": [ "P980040" ], "product_description": "Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter.\n\nThe Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.", "code_info": "5185681009\t5186101009 5185691009\t5186111009 5185701009\t5186121009 5185711009\t5186131009 5185721009\t5186141009 5185731009\t5186151009 5185741009\t5186161009 5185751009\t5186171009 5185761009\t5186181009 5185771009\t5186191009 5185781009\t5186201009 5185791009\t5186211009 5185801009\t5186221009 5185811009\t5186231009 5185821009\t5186241009 5185831009\t5186251009 5185841009\t5186261009 5185851009\t5186271009 5185861009\t5186281009 5185871009\t5186291009 5185881009\t5186301009 5185891009\t5186311009 5185901009\t5186321009 5185911009\t5186331009 5185921009\t5186341009 5185931009\t5186351009 5185941009\t5186361009 5185951009\t5186371009 5185961009\t5186381009 5185971009\t5186391009 5185981009\t5186401009 5185991009\t5186411009 5186001009\t5186421009 5186011009\t5186431009 5186021009\t5186441009 5186031009\t5186451009 5186041009\t5186461009 5186051009\t5186471009 5186061009\t5186491009 5186071009\t5186501009 5186081009\t5186511009 5186091009", "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": "92705-4933", "additional_info_contact": "714-247-8656", "reason_for_recall": "The firm is initiating this voluntary recall because of the possibility that certain Sensar IOLs are labeled with an incorrect diopter power.", "root_cause_description": "Employee error", "action": "Abbott Medical Optics, Inc. sent an URGENT FIELD SAFETY NOTICE dated September 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using and remove the affected product from their inventory, complete and return the included facsimile form to Abbott Medical Optics and indicate the status of each affected serial number on the form. Customers were asked to return the form even if they have no inventory affected by the recall. \nFor any questions customers were instructed to contact their Abbott Medical Optics Customer Service Representative.\nFor any questions regarding this recall call 714-247-8656.", "product_quantity": "83", "distribution_pattern": "Worldwide Distribution including China, India, Indonesia, Korea, Malasyia, Taiwan, Thailand, Austria, Finland, France, Germany, Great Britain, Hungary, Italy, Netherlands, Portugal, and Saudy Arabia", "openfda": { "k_number": [ "K913626", "K842504", "K914311", "K771933", "K842892" ], "pma_number": [ "P840039", "P910061", "P870013", "P100016", "P860059", "P880085", "P880082", "P080021", "P810032", "P040020", "P850059", "P820049", "P810055", "P900037", "P910060", "P880091", "P810056", "P820072", "P820044", "P080004", "P990013", "P880070", "P060011", "P990080", "P990014", "P860002", "P830033", "P940007", "P240038", "P910056", "P830056", "P870073", "P880010", "P870045", "P980040", "P060022", "P890056", "P010027", "P820035", "P810018", "P860034", "P900048", "P880087", "P790027", "P900053", "P930014", "P810042", "P190018", "P840060", "P910058", "P800049", "P820016", "P800017", "P090022", "P840050", "P960036", "P960034", "P880090", "P830040", "P800027", "P840033", "P800016", "P970034", "P890068", "P870075", "P880081", "P880072", "P810001" ], "registration_number": [ "2029275", "2032098", "2031928", "3002807314", "3010148516", "1054811", "1211998", "1281950", "3010155661", "2031474", "3003304724", "9614429", "2023826", "2011171", "2031959", "9681121", "3007207818", "3008344633", "3010126268", "3020977988", "9613160", "2438659", "3007530141", "3015456951", "3012236936", "1037089", "3008449456", "1048735", "2648035", "3013202565", "2953359", "9681630", "2030624", "3006723646", "3012304651", "1064514", "3017636737", "2246552", "3024715547", "2529709", "3014173684", "1063199", "3010413216", "3008641313", "3007125265", "9614546", "2020277", "9710098", "3006946276", "3014002883", "1038833", "1119279", "3017435679", "1313525", "1610287", "1119421", "9612169" ], "fei_number": [ "3004161528", "3002807314", "3010148516", "1281950", "1211998", "3010155661", "3003304724", "3004651700", "2023826", "2011171", "1000121259", "3007207818", "3008344633", "3010126268", "3020977988", "3007530141", "3015456951", "3012236936", "1317628", "1037089", "3008449456", "1048735", "2648035", "3002936283", "3002808845", "3002807944", "3013202565", "3003088462", "1000306431", "3002777043", "3006723646", "3012304651", "3017636737", "3002808262", "3002023310", "3001284430", "2246552", "3024715547", "1000114185", "3014173684", "3002808259", "3010413216", "3001659659", "3008641313", "3000215205", "3007125265", "2020277", "3006946276", "3014002883", "1038833", "1119279", "3017435679", "3000206435", "1610287", "1119421", "3002957101", "3003058448" ], "device_name": "Intraocular Lens", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.3600", "device_class": "3" } } ] }