{
  "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": "141006",
      "product_res_number": "Z-0237-2016",
      "event_date_initiated": "2015-09-29",
      "event_date_posted": "2015-11-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-12-03",
      "res_event_number": "72434",
      "product_code": "HQL",
      "product_description": "TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811",
      "code_info": "SN: U07310001 thru U07310040 , 07310050 thru U07310059",
      "firm_fei_number": "3002023310",
      "recalling_firm": "Tekia,  Inc.",
      "address_1": "17 Hammond Ste 414 17 Hammond",
      "address_2": "Ste 414",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92618-1635",
      "additional_info_contact": "949-699-1300",
      "reason_for_recall": "Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.",
      "root_cause_description": "Error in labeling",
      "action": "Tekia sent an Field Safety Notice dated September 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. \n\nCustomers were advised that Tekia is recalling a limited a number of Single Piece Hydrophilic Acrylic IOLs. If the customer has any questions, the customer is instructed to contact a TEKIA Customer Service or QA Representative at (949) 699-1300.  Customers with product complaints or adverse events regarding the use of Single Piece Hydrophilic Acrylic IOLs are instructed to inform TEKIA by phone, email, or fax.",
      "product_quantity": "50 units",
      "distribution_pattern": "Internationally to Vietnam.",
      "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"
      }
    }
  ]
}