{ "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": "42549", "product_res_number": "Z-0093-06", "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": "Tecnis Monofocal Silicone Posterior Chamber IOLs (Models: Z9000 and Z9001)", "code_info": "Tecnis¿ Silicone Z9000, 94 lenses   Tecnis Mono 12mm Z9000+11,5 \t8160800508\t\t Tecnis Mono 12mm Z9000+23,0\t8014050508 Tecnis Mono 12mm Z9000+12,0 \t8110100508\t\t \t8014060508  \t8110110508\t\t \t8014070508 Tecnis Mono 12mm Z9000+20,5 \t8095430509\t\t \t8014090508 Tecnis Mono 12mm Z9000+21,0 \t8062320509\t\t \t8014100508 Tecnis Mono 12mm Z9000+22,0 \t8094140509\t\t \t8014110508  \t8094150509\t\t \t8014120508 Tecnis Mono 12mm Z9000+22,5 \t8080300509\t\t \t8014130508  \t8080310509\t\t \t8014140508  \t8117480508\t\t \t8014150508 Tecnis Mono 12mm Z9000+23,0 \t8012330508\t\t \t8014160508  \t8012340508\t\t \t8014190508  \t8012360508\t\t Tecnis Mono 12mm Z9000+23,5 \t8160360508  \t8012370508\t\t Tecnis Mono 12mm Z9000+24,0 \t8166940508  \t8012380508\t\t \t8166960508  \t8012400508\t\t \t8166970508  \t8012410508\t  \t8012430508\t  \t8012440508\t  \t8012450508\t  \t8012460508\t  \t8012470508\t  \t8012480508\t  \t8012510508\t  \t8012530508\t  \t8012540508\t  \t8013910508\t  \t8013920508\t  \t8013930508\t  \t8013940508\t  \t8013950508\t  \t8013960508\t  \t8013970508\t  \t8013980508\t  \t8013990508\t  \t8014000508\t  \t8014010508\t  \t8014020508\t  \t8014030508\t  \t8014040508\t  Tecnis Mono 12mm Z9000+24,5 \t8037770508  \t8037780508  \t8037790508  \t8037800508  \t8037810508  \t8037820508  \t8037830508  \t8037840508  \t8037850508  \t8037860508  \t8037870508  \t8037880508  \t8037890508  \t8037900508  \t8037910508  \t8037920508  \t8037930508  \t8037940508  \t8037950508  \t8037960508  \t8037970508  \t8037980508  \t8037990508  \t8163880508  \t8163890508  \t8163900508  \t8163910508  \t8163920508  \t8163930508  \t8163940508  \t8163950508  \t8163960508  \t8163970508  \t8163980508  \t8163990508  \t8164000508  \t8164010508  \t8164020508   Tecnis¿ Silicone Z9001, 13 lenses  Tecnis Mono 13mm Z9001+22.5 \t8030920508  \t8030930508  \t8031100508  \t8031110508  \t8031130508  \t8031140508  \t8031150508 Tecnis Mono 13mm Z9001+25,5 \t8111960508  \t8111970508  \t8111980508  \t8111990508  \t8112000508  \t8112020508", "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": "107 (39 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" } } ] }