{ "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": "86507", "product_res_number": "Z-0605-2010", "event_date_initiated": "2009-11-11", "event_date_posted": "2010-01-12", "recall_status": "Terminated", "event_date_terminated": "2012-07-25", "res_event_number": "53781", "product_code": "HQL", "pma_numbers": [ "P980040S015" ], "product_description": "AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)", "code_info": "All Serial numbers of tecnis 1-Piece Intraocular Lenses that were processed through lens surface treatment at the AMO PR facility between May 19 and October 16, 2009 - with serial numbers ending in 0906, 0907, 0908, and 0909. and subset with serial numbers ending in 0905 and 0910.  Expiration/Use By Date (YYYY-MM): 2011-05, 2011-06, 2011-07, 2011-08, 2011-09, and 2011-10", "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", "additional_info_contact": "714-247-8656", "reason_for_recall": "Abbott Medical Optics (AMO) has received complaints of some Tecnis 1-Piece IOLs (model ZCB00) have adhered to the lens optic after insertion into the eye. This can lead to a need for additional manipulation to separate the haptics from the optic during surgery which could lead to an injury.", "root_cause_description": "Process design", "action": "Beginning on Friday, November 6, 2009, AMO began distribution of the Recall Notification Letter via Federal Express to the 874 AMO Tecnis 1-piece IOL customer accounts in the US. Included with the Recall Notification letter is a facsimile delivery confirmation that each customer was instructed to fax back to AMO to confirm receipt of the Recall Notification Letter. --- Beginning on Monday, November 9, 2009, AMO began distribution of the Recall Notification letter to the AMO Tecnis 1-piece IOL customer/distributors accounts outside the USA.\n\n\"THIS RECALL NOTIFICATION DOES NOT INVOLVE TECNIS 1-PIECE IOL THAT HAVE BEEN IMPLANTED. ONCE THE HAPTICS HAVE BEEN SUCCESSFULLY DEPLOYED, THESE LENSES FUNCTION PROPERLY.\"\n\nQuestions should be directed to an AMO Customer Service Representative at 1-877-AMO-4LIFE (1-877-266-4543).", "product_quantity": "246000 Lenses", "distribution_pattern": "AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, Hawaii, and Puerto Rico.\n\nINTERNATIONAL: Austria, Azerbaijan, Belgium, Canada, Switzerland, Cyprus, Czech Republic, Germany, Estonia, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Italy, Lebanon, Lichtenstein, Libya, Martinique, Netherlands, Poland, Palestine, Portugal, Saudi Arabic, Sweden, Slovenia, Turkey, and South Africa.", "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" } } ] }