{
  "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": [
    {
      "country": "United States",
      "city": "Anasco",
      "address_1": "Rd # 402, Km 4.2",
      "reason_for_recall": "Units may be labeled with the incorrect diopter power.",
      "address_2": "",
      "product_quantity": "77,055 IOLs in total",
      "code_info": "Serial Num  1101821309  1101831309  1101841309  1101861309  1101881309  1101901309  1101921309  1101941309  1101981309  1101991309  1102001309  1102011309  1102031309  1102051309  1102071309  1102091309  1102111309  1102131309  1102201309  1102211309  1102221309  1102231309  1102241309  1102261309  1102271309  1102291309  1102301309  1102311309  1102321309  1102331309  1102351309  1102371309  1102381309  1102391309  1102401309  1102411309  1102431309  1102461309  1102481309  1102501309  1102551309  1102621309  1102641309  1102651309  1102661309  1102681309  1102811309  1102831309  1102851309  1102871309  1102911309  1102941309  1289831308  1289841308  1289851308  1289861308  1289871308  1289881308  1289891308  1289901308  1289911308  1289921308  1289931308  1289941308  1289961308  1290001308  1290021308  1290041308  1290061308  1290071308  1290081308  1290091308  1290101308  1290111308  1290121308  1290141308  1290161308  1290171308  1290181308  1290191308  1290201308  1290211308  1290231308  1290251308  1290271308  1290281308  1290291308  1290311308  1290321308  1290331308  1290341308  1290351308  1290361308  1290371308  1290381308  1039861309  1039881309  1039901309  1039961309  1039981309  1040011309  1040021309  1040041309  1040121309  1040151309  1040161309  1040171309  1040181309  1040191309  1040201309  1040211309  1040231309  1040251309  1040271309  1040291309  1040311309  1040331309  1040351309  1040371309  1040391309  1040471309  1040501309  1040551309  1040571309  1040591309  1040671309  1040711309  1040771309  1048531309  1048541309  1048551309  1048561309  1048571309  1048591309  1048601309  1048611309  1048621309  1048631309  1048641309  1048661309  1048671309  1048681309  1048691309  1048701309  1048711309  1048721309  1048731309  1048741309  1048751309  1048761309  1048771309  1048781309  1048801309  1048811309  1048841309  1048911309  1048921309  1048931309  1048941309  1048951309  1048971309  1048981309  1048991309  1049001309  1049021309  1049031309  1049041309  1049051309  1049071309  1049101309  1049121309  1049141309  1049161309  1049181309  1049201309  1049211309  1049221309  1049251309  1049271309  1049291309  1049321309  1049331309  1049341309  1049361309  1049371309  1049391309  1049401309  1049411309  1049421309  1049431309  1049441309  1049451309  1049461309  1049471309  1049481309  1049491309  1049501309  1049511309  1066121309  1066131309  1066161309  1066181309  1066211309  1066221309  1066231309  1066251309  1066261309  1066321309  1066361309  1066401309  1066441309  1066481309  1066521309  1066561309  1066571309  1066591309  1066601309  1066641309  1066661309  1066761309  1066951309  1066971309  1067041309  1067061309  1067081309  1067101309  1067121309  1067141309  1067151309",
      "center_classification_date": "20140819",
      "distribution_pattern": "Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign:  Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.",
      "state": "PR",
      "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: 29, 29.5 & 30.    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.",
      "report_date": "20140827",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "AMO Puerto Rico Manufacturing, Inc.",
      "recall_number": "Z-2287-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68346",
      "termination_date": "20170518",
      "more_code_info": "",
      "recall_initiation_date": "20140513",
      "postal_code": "00610",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}