{ "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": "167198", "product_res_number": "Z-0108-2019", "event_date_initiated": "2018-06-25", "event_date_created": "2018-10-15", "recall_status": "Terminated", "event_date_terminated": "2021-01-15", "res_event_number": "81000", "product_code": "HJO", "k_numbers": [ "K170171" ], "product_description": "Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany,\nIOLMaster 700, REF 1932-169\nSN 1185393\n2017-09-01", "code_info": "Model: 700 Catalog Number: 000000-1932-169 Serial Number: 1185393 UDI: 04049471092080", "firm_fei_number": "3001362763", "recalling_firm": "Carl Zeiss Meditec AG", "address_1": "Carl-Zeiss-Promenade 10 10 carl-zeiss-promenade", "city": "Jena", "country": "Germany", "reason_for_recall": "Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye.", "root_cause_description": "Employee error", "action": "On 08/06/2018 the firm sent a Field Safety Corrective Action letter to customers via FedEx Priority Overnight service informing them that based on routine post market surveillance activities, we have information that this specific IOLMaster 700 device is incorrectly calibrated. The calibration value for axial length measurement was not entered correctly in the device settings during\nthe manufacturing process. The transmission discrepancy leads to an error during the axial length measurement of approx. 0.25mm. A deviation in the axial length of this magnitude results in an error of Single unit. approx. 0.8 Diopter with regard to the intraocular lens. This in turn results in a refractive error of about 0.5 Diopter. The local firm's service organization will remove this device from the field. The device manufacturer will recalibrate the device to ensure it meets specifications.\n\nHazard involved:\nThe likelihood of a faulty entered calibration value for axial length measurement in the production process\nof IOLMaster 700 is considered rare. The probability of injury, i.e. reduced visual acuity due to the\nimplantation of a wrong IOL power, is very likely for the affected device, because the axial length of the eye\ncannot be measured correctly. The device failure may only be recognized through post-surgical examination.\n\nAffected product:\nQuantity: 1\nProduct Name: IOLMaster 700\nProduct Number: 000000-1932-169\nDevice Serial Number: 1185393\nManufacturing Date: 2017-09-18\n \nActions to be taken:\n1. Discontinue use of the ZEISS IOLMaster 700 device (Serial Number 1185393). Physicians are asked to review refractive results during usage of this device and to inform the firm about any hyperopic refractive surprises noticed. Any measurement and calculation data from this device should not be taken into consideration for further treatments.\n2. Complete and return the attached Medical Device Recall Return Response Form to USFCA.meditec.us@zeiss.com no later than Jun", "product_quantity": "1", "distribution_pattern": "US: CA (Mountain View and San Jose)\n\nA single system.\nNo distributed OUS.", "openfda": { "k_number": [ "K912514", "K141954", "K012416", "K810403", "K060869", "K924770", "K802355", "K954782", "K992836", "K162778", "K182306", "K936209", "K131589", "K953030", "K072861", "K153545", "K862520", "K813313", "K173771", "K063416", "K863048", "K110129", "K161607", "K924782", "K993357", "K953965", "K171877", "K133755", "K131711", "K012873", "K951340", "K913852", "K063352", "K110489", "K253834", "K880920", "K131567", "K193188", "K862379", "K945445", "K063640", "K093021", "K801659", "K133132", "K141068", "K140451", "K930518", "K043503", "K100202", "K915356", "K951184", "K842859", "K930438", "K133476", "K944910", "K082031", "K924787", "K061330", "K170470", "K973064", "K874160", "K982057", "K900476", "K163564", "K162684", "K133062", "K160327", "K231760", "K962532", "K162636", "K122418", "K971953", "K970414", "K862004", "K962522", "K832911", "K900477", "K951341", "K811153", "K862516", "K092883", "K170171", "K925641", "K101182", "K082891", "K033190", "K133667", "K222372", "K863970", "K951054", "K152535", "K862515", "K100500", "K080776", "K063750", "K073190", "K152429", "K100439", "K151394", "K974467", "K861854", "K924783", "K093639", "K161764", "K874220", "K161972", "K910980", "K143275" ], "registration_number": [ "3013403214", "2918630", "3005527296", "9611269", "2952604", "9710516", "1000176188", "3004441848", "8020986", "3012423824", "2242863", "2521877", "3010227033", "3009746052", "3010610157", "9614661", "3015972897", "2080939", "3003144120", "3005755367", "3004438257", "3008729548", "3038356864", "3033566", "1226587", "3007913988", "3005785090", "9612297", "1000391004", "1926681", "3005771344", "3014342096", "2027009", "2936921", "9616199", "9615010", "3010202439", "3009173773", "3004095901", "3002807715", "1937310", "9615030", "1319721", "3003553186", "3010675798", "2939653", "1054713", "3011898560", "9617474", "8030392", "3020723591", "3015316279", "2020550", "3011223751", "3008169506", "3011442035" ], "fei_number": [ "3013403214", "2918630", "3005527296", "1000114111", "3002809378", "4196", "3004099094", "1000176188", "3004441848", "1000159913", "3012423824", "2242863", "3002785343", "2521877", "3010227033", "3009746052", "3007475226", "3010610157", "3015972897", "2080939", "1000175127", "3005755367", "3003481798", "3004438257", "3008729548", "3038356864", "3007913988", "3005785090", "3002398337", "3001802794", "1000391004", "1926681", "3005771344", "3014342096", "2027009", "2936921", "3000210228", "3001362763", "3009173773", "3002807782", "3004095901", "3002807715", "1937310", "3003553186", "3003768492", "3010675798", "2939653", "3011898560", "2020550", "3020723591", "3015316279", "3011223751", "3008169506", "3011442035", "3003046678" ], "device_name": "Biomicroscope, Slit-Lamp, Ac-Powered", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.1850", "device_class": "2" } } ] }