{ "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": "104241", "product_res_number": "Z-0276-2012", "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 21.5 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": "5058981009\t5059401009\t5059831009 \t5058991009\t5059411009\t5059841009 \t5059001009\t5059421009\t5059851009 \t5059011009\t5059431009\t5059861009 \t5059021009\t5059441009\t5059871009 \t5059031009\t5059451009\t5059881009 \t5059041009\t5059461009\t5059891009 \t5059051009\t5059471009\t5059901009 \t5059061009\t5059481009\t5059911009 \t5059071009\t5059491009\t5059921009 \t5059081009\t5059501009\t5059931009 \t5059091009\t5059511009\t5059941009 \t5059101009\t5059521009\t \t5059111009\t5059531009\t \t5059121009\t5059541009\t \t5059131009\t5059551009\t \t5059141009\t5059561009\t \t5059151009\t5059571009\t \t5059161009\t5059581009\t \t5059171009\t5059591009\t \t5059181009\t5059601009\t \t5059191009\t5059611009\t \t5059201009\t5059621009\t \t5059211009\t5059631009\t \t5059221009\t5059641009\t \t5059231009\t5059651009\t \t5059241009\t5059661009\t \t5059251009\t5059671009\t \t5059261009\t5059681009\t \t5059271009\t5059691009\t \t5059281009\t5059701009\t \t5059291009\t5059711009\t \t5059301009\t5059721009\t \t5059311009\t5059731009\t \t5059321009\t5059741009\t \t5059331009\t5059761009\t \t5059341009\t5059771009\t \t5059351009\t5059781009\t \t5059361009\t5059791009\t \t5059371009\t5059801009\t \t5059381009\t5059811009\t \t5059391009\t5059821009", "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": "96", "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": [ "K842504", "K842892", "K771933", "K914311", "K913626" ], "pma_number": [ "P870073", "P980040", "P900048", "P830056", "P880090", "P970034", "P910060", "P080004", "P790027", "P840033", "P820049", "P100016", "P060022", "P240038", "P860034", "P990014", "P880081", "P090022", "P930014", "P880070", "P870045", "P830040", "P060011", "P040020", "P900037", "P880010", "P910058", "P820035", "P800017", "P810032", "P960034", "P890068", "P990013", "P810001", "P880072", "P810042", "P820072", "P010027", "P910061", "P880085", "P880091", "P960036", "P910056", "P830033", "P820044", "P860002", "P190018", "P880082", "P800016", "P820016", "P810056", "P850059", "P880087", "P810018", "P840039", "P810055", "P870013", "P860059", "P080021", "P870075", "P900053", "P800027", "P840060", "P940007", "P890056", "P990080", "P840050", "P800049" ], "registration_number": [ "3010126268", "3006723646", "3014002883", "1119279", "3012304651", "1281950", "3007125265", "3017435679", "2030624", "3015456951", "2032098", "2529709", "1313525", "2020277", "3014173684", "9614429", "3002807314", "1119421", "2031474", "9681630", "9614546", "1211998", "3007530141", "3010148516", "1048735", "2031959", "3007207818", "1064514", "9613160", "2438659", "3020977988", "3013202565", "9710098", "9681121", "3024715547", "2023826", "2011171", "3010413216", "3012236936", "3008344633", "2953359", "3006946276", "3017636737", "3010155661", "2246552", "1610287", "2029275", "1054811", "1038833", "1037089", "3008449456", "9612169", "3003304724", "1063199", "2031928", "3008641313", "2648035" ], "fei_number": [ "3010126268", "3006723646", "3014002883", "1119279", "3012304651", "1281950", "3007125265", "3017435679", "3015456951", "3002777043", "2020277", "3014173684", "3002936283", "3002807314", "3002808262", "3000215205", "1119421", "3002808259", "1211998", "3007530141", "3010148516", "1048735", "3002807944", "3007207818", "1000121259", "3020977988", "3001659659", "3002023310", "3013202565", "3004161528", "1000114185", "3024715547", "1317628", "2023826", "2011171", "3010413216", "3012236936", "3008344633", "3006946276", "3003088462", "3004651700", "3002957101", "3010155661", "1000306431", "2246552", "1610287", "3017636737", "3001284430", "1038833", "1037089", "3008449456", "3000206435", "3003304724", "3003058448", "3008641313", "2648035", "3002808845" ], "device_name": "Intraocular Lens", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.3600", "device_class": "3" } } ] }