{
  "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": "1003871311 1042751309 1166801309  1003911311 1042761309 1166811309  1003931311 1042771309 1166821309  1003951311 1042781309 1166831309  1003971311 1042801309 1166841309  1003991311 1042821309 1166851309  1004011311 1042841309 1166861309  1004501311 1042861309 1166871309  1004521311 1042881309 1166881309  1004561311 1042901309 1166891309  1004581311 1042941309 1166901309  1004601311 1042961309 1166911309  1004621311 1043061309 1166921309  1004631311 1043081309 1166941309  1004641311 1043121309 1166961309  1004661311 1043141309 1166971309  1004671311 1043161309 1166981309  1004681311 1166391309 1166991309  1042091309 1166431309 1167001309  1042111309 1166441309 1167021309  1042191309 1166451309 1167041309  1042271309 1166471309 1167051309  1042291309 1166481309 1167061309  1042311309 1166511309 1167081309  1042331309 1166531309 1167101309  1042351309 1166561309 1167111309  1042391309 1166581309 1167131309  1042481309 1166601309 1167141309  1042571309 1166621309 1167151309  1042581309 1166631309 1167161309  1042591309 1166641309 1167171309  1042601309 1166661309 1167181309  1042611309 1166671309 1167201309  1042621309 1166681309 1167221309  1042631309 1166691309 1167241309  1042641309 1166701309 1167251309  1042651309 1166711309 1167261309  1042671309 1166721309 1167271309  1042681309 1166731309 1167281309  1042691309 1166741309 1167291309  1042701309 1166751309 1167301309  1042711309 1166761309 1167311309  1042721309 1166771309 1167321309  1042731309 1166781309 1167331309  1042741309 1166791309 1167351309  1167371309  1167391309  1167411309  1167431309  1167441309  1167451309  1167461309  1013301309 1014161309  1013311309 1014171309  1013331309 1014191309  1013351309 1014231309  1013391309 1014251309  1013411309 1014261309  1013431309 1014281309  1013451309 1014301309  1013511309 1014321309  1013531309 1014341309  1013551309 1014351309  1013561309 1083721309  1013571309 1083731309  1013581309 1083751309  1013601309 1083851309  1013611309 1083871309  1013621309 1083881309  1013641309 1083891309  1013661309 1083901309  1013701309 1083911309  1013721309 1083921309  1013741309 1083931309  1013761309 1083991309  1013771309 1084021309  1013791309 1084061309  1013811309 1084081309  1013821309 1084091309  1013831309 1084111309  1013841309 1084121309  1013851309 1084131309  1013861309 1084141309  1013871309 1084151309  1013891309 1084161309  1013921309 1084171309  1013941309 1084181309  1013961309 1084191309  1013981309 1084201309  1014021309 1084211309  1014051309 1084221309  1014071309 1084231309  1014091309 1084241309  1014121309 1084251309  1014131309 1084261309  1014141309 1084271309  1014151309 1084281309  1084291309  1084301309  1084311309  1084321309  1084341309  1084361309  1084381309  1084391309  1084401309  1084411309  1084421309  1084441309  1084461309  1084481309  1084491309  1217341310  1217391310  1217421310  1217441310  1217461310  1217481310  1217521310  1217541310  1217561310  1217581310  1217601310  1217621310  1217801310  1217811310  1004031311  1004051311  1042501309  1042521309  1042531309  1042551309  1042811309  1166521309  1166571309  1166611309  1013491309  1083711309  1083771309  1216881310",
      "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: 10.0 and 10.5    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.",
      "report_date": "20140827",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "AMO Puerto Rico Manufacturing, Inc.",
      "recall_number": "Z-2272-2014",
      "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"
    }
  ]
}