{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "42553", "product_res_number": "Z-0095-06", "event_date_initiated": "2005-10-05", "event_date_posted": "2005-10-28", "recall_status": "Terminated", "event_date_terminated": "2008-05-23", "res_event_number": "33849", "product_code": "HQL", "pma_numbers": [ "P990080" ], "product_description": "CeeOn EDGE Silicone\nPosterior Chamber IOLs\n(Modelsl 911A and 913A)", "code_info": "CeeOn¿ EDGE Silicone 911A, 189 lenses  SLMP 911A +10,0 \t8131520508 SLMP 911A +11,5 \t8116020508  \t8116050508  \t8116060508 SLMP 911A +13,0 \t8189380508 SLMP 911A +13,5 \t8108000508 SLMP 911A +14,0 \t8033720508  \t8090160508  \t8224980508 SLMP 911A +15,0 \t8105650508  \t8105660508  \t8105680508  \t8105690508  \t8105730508  \t8105740508  \t8105760508  \t8105770508  \t8105790508 SLMP 911A +15,5 \t8064660508  \t8064800508  \t8186100508  \t8186110508 SLMP 911A +16,5 \t8063190508  \t8063270508  \t8063280508  \t8063290508  \t8063300508  \t8063310508 SLMP 911A +17,0 \t8062880508  \t8062920508  \t8062960508  \t8062970508  \t8062980508  \t8063000508  \t8236490508 SLMP 911A +17,5 \t8047590508  \t8047830508 SLMP 911A +18,0 \t8058440508  \t8058450508  \t8058460508  \t8058470508  \t8058490508  \t8058500508  \t8058520508 SLMP 911A +18,5 \t8058030508  \t8058110508  \t8058350508  \t8058360508  \t8139110508  \t8139150508 SLMP 911A +19,5 \t8047170508  \t8047180508  \t8047200508  \t8047210508  \t8047220508  \t8047250508  \t8047340508  \t8047360508 SLMP 911A +21,5 \t8082640508  \t8082660508  \t8082670508  \t8082680508  \t8082740508  \t8082750508  \t8082760508  \t8082770508  \t8082780508  \t8082920508  \t8084420508  \t8084670508 SLMP 911A +22,0 \t8056570509  \t8056590509  \t8164620508 SLMP 911A +22,5 \t8081650508  \t8081710508  \t8081770508  \t8081790508  \t8081820508  \t8081830508  \t8081840508  \t8081850508  \t8081860508  \t8081870508  \t8108460508  \t8108470508  \t8108500508  \t8108510508  \t8108520508  \t8108560508  \t8108650508  \t8165340508  \t8165350508  \t8165360508  \t8165370508  \t8165380508  \t8165390508  \t8165400508  \t8165410508  \t8165420508  \t8165430508 SLMP 911A +23,0 \t8085040508  \t8085050508  \t8085060508  \t8085080508  \t8085090508  \t8085100508  \t8085120508  \t8085130508  \t8085140508  \t8085150508  \t8085160508  \t8085170508  \t8085180508  \t8085190508  \t8085220508  \t8085230508  \t8086900508  \t8086910508  \t8086920508  \t8086930508  \t8086940508  \t8087040508  \t8087050508  \t8087060508  \t8087070508  \t8087080508  \t8176340508 SLMP 911A +24,0 \t8089850508  \t8089910508  \t8175230508  \t8175260508  \t8194110508  \t8194120508  \t8194130508  \t8194140508  \t8194160508  \t8194180508  \t8194820508  \t8194910508  \t8194950508  \t8195360508  \t8195370508  \t8195410508  \t8195470508  \t8195520508 SLMP 911A +24,5 \t8084090508  \t8084100508  \t8084200508  \t8089000508  \t8168060508 SLMP 911A +25,0 \t8067040508  \t8067300508 SLMP 911A +25,5 \t8084740508  \t8084770508  \t8084780508  \t8084790508  \t8084940508  \t8084950508  \t8092820508 SLMP 911A +26,5 \t8100530508  \t8100540508  \t8100560508  \t8100640508  \t8100660508 SLMP 911A +27,0 \t8099340508  \t8099380508 SLMP 911A +28,0 \t8085670508  \t8085950508  \t8085960508 SLMP 911A +28,5 \t8077790508  \t8077860508  \t8102970508  \t8103030508  \t8103040508  \t8103080508  \t8103090508  \t8103100508  \t8103120508  \t8103130508  \t8103140508 SLMP 911A +29,0 \t8096860508  \t8096900508 SLMP 911A +29,5 \t8095320508  \t8095330508 SLMP 911A +30,0 \t8106430508  \t8106440508  \t8106450508  \t8106460508  \t8106470508  CeeOn¿ EDGE Silicone 913A, 103 lenses   SLMP 913A +11,0 \t8184650508 SLMP 913A +15,5 \t8171590508 SLMP 913A +18,5 \t8177910508  \t8177920508  \t8177960508  \t8177970508  \t8178040508 SLMP 913A +19,0 \t8053490508  \t8053520508  \t8053530508  \t8181070508 SLMP 913A +19,5 \t8052440508  \t8052460508  \t8052470508  \t8052480508  \t8052680508 SLMP 913A +20,0 \t8053300508 SLMP 913A +20,5 \t8245300508  \t8245310508  \t8245320508  \t8245330508  \t8245340508  \t8245350508  \t8245370508  \t8245420508  \t8245430508  \t8245440508  \t8245450508  \t8245460508  \t8245470508  \t8245540508  \t8245570508 SLMP 913A +21,0 \t8179350508  \t8179360508  \t8179370508  \t8179380508  \t8179390508  \t8179400508  \t8179450508  \t8179460508  \t8183440508  \t8183520508  \t8183540508  \t8183550508  \t8183560508  \t8183570508  \t8183580508 SLMP 913A +22,0 \t8035910509  \t8070510508  \t8180690508  \t8180700508  \t8180710508  \t8180720508  \t8180730508  \t8180740508  \t8180750508  \t8180760508  \t8180770508 SLMP 913A +22,5 \t8227980508  \t8227990508  \t8228000508  \t8228010508  \t8228020508  \t8228050508  \t8228200508  \t8228210508  \t8228220508 SLMP 913A +23,0 \t8227170508  \t8227210508  \t8227220508  \t8227240508  \t8227250508  \t8227260508  \t8227270508 SLMP 913A +23,5 \t8077180508  \t8077230508  \t8077240508  \t8077280508  \t8180250508  \t8180260508 SLMP 913A +24,0 \t8176510508  \t8176520508  \t8176530508  \t8176540508  \t8176550508  \t8176560508  \t8176570508  \t8176580508  \t8176590508  \t8176600508  \t8176610508  \t8176620508  \t8181330508  \t8181380508  \t8181390508  \t8181400508 SLMP 913A +24,5 \t8078360508  \t8178480508  \t8178680508  \t8178690508 SLMP 913A +25,0 \t8182890508  \t8182900508  \t8182930508", "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": "A small opening (channel or tunnel) in the seal of the\nouter Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.", "root_cause_description": "Other", "action": "A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.", "product_quantity": "292 (28 in US)", "distribution_pattern": "Nationwide, Austria, Belgium, Switzerland, Germany, Denmark, France, UK, Guadelope, Hong Kong, Croatia, \nIndia, Italy, Netherlands, and Vietnam", "openfda": { "pma_number": [ "P930014", "P880010", "P800017", "P810056", "P870045", "P880081", "P860002", "P880087", "P830040", "P820049", "P880091", "P870073", "P880070", "P810018", "P860059", "P040020", "P810032", "P870013", "P960034", "P990013", "P880090", "P900053", "P060011", "P870075", "P980040", "P830056", "P990080", "P810001", "P830033", "P990014", "P840050", "P900048", "P900037", "P910060", "P880082", "P800016", "P240038", "P810042", "P820072", "P800027", "P840060", "P820035", "P100016", "P190018", "P840039", "P970034", "P090022", "P810055", "P940007", "P850059", "P960036", "P910056", "P880072", "P010027", "P080004", "P910061", "P800049", "P840033", "P790027", "P890056", "P820044", "P820016", "P890068", "P860034", "P910058", "P080021", "P880085", "P060022" ], "registration_number": [ "1211998", "2020277", "1063199", "3006723646", "3010126268", "2011171", "3007530141", "1054811", "3017435679", "3010155661", "9681121", "2031474", "3013202565", "2031959", "1610287", "3012304651", "2029275", "2032098", "1313525", "2031928", "3008641313", "3010148516", "1048735", "2246552", "9681630", "9614429", "1119279", "2023826", "2529709", "9613160", "3024715547", "3003304724", "3007207818", "3006946276", "9710098", "3010413216", "3014173684", "1037089", "3014002883", "1281950", "9612169", "1064514", "2030624", "3002807314", "2438659", "3008344633", "3015456951", "3020977988", "2953359", "3012236936", "3007125265", "9614546", "1119421", "3008449456", "3017636737", "1038833", "2648035" ], "fei_number": [ "1211998", "2020277", "3006723646", "3010126268", "2011171", "3001659659", "3007530141", "3017435679", "3010155661", "3002957101", "1000121259", "3013202565", "1610287", "3004651700", "3012304651", "3002808259", "3002807944", "1000114185", "1000306431", "3008641313", "3004161528", "3010148516", "1048735", "2246552", "1119279", "2023826", "3001284430", "3002808845", "3024715547", "3003304724", "3007207818", "3006946276", "3002777043", "3000215205", "3002936283", "3010413216", "3014173684", "1037089", "3014002883", "3002808262", "1281950", "3000206435", "1317628", "3002807314", "3003058448", "3008344633", "3002023310", "3015456951", "3020977988", "3012236936", "3007125265", "1119421", "3008449456", "3017636737", "3003088462", "1038833", "2648035" ], "k_number": [ "K842892", "K913626", "K914311", "K842504", "K771933" ], "device_name": "Intraocular Lens", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.3600", "device_class": "3" } } ] }