{ "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": "2026-04-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Anasco", "state": "PR", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "68346", "recalling_firm": "AMO Puerto Rico Manufacturing, Inc.", "address_1": "Rd # 402, Km 4.2", "address_2": "", "postal_code": "00610", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.", "recall_number": "Z-2271-2014", "product_description": "AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.", "product_quantity": "77,055 IOLs in total", "reason_for_recall": "Units may be labeled with the incorrect diopter power.", "recall_initiation_date": "20140513", "center_classification_date": "20140819", "termination_date": "20170518", "report_date": "20140827", "code_info": "1193901309 1193981309 1194001309 1194021309 1194041309 1194061309 1194081309 1194101309 1194121309 1194141309 1194161309 1194181309 1194191309 1194201309 1194221309 1194231309 1194251309 1194321309 1194351309 1194371309 1194411309 1194541309 1194551309 1194591309 1194611309 1194631309 1194651309 1194801309 1301391308 1301411308 1301471308 1301491308 1301511308 1301531308 1301551308 1301571308 1301591308 1301611308 1301631308 1301671308 1301751308 1301981308 1039461309 1039481309 1039521309 1039541309 1039561309 1039581309 1039601309 1039621309 1039641309 1114081309 1114411309 1114431309 1114621309 1114841309 1114861309 1114871309 1114881309 1114891309 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