{
  "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": "130762",
      "product_res_number": "Z-0529-2015",
      "event_date_initiated": "2014-10-28",
      "event_date_posted": "2014-12-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-10-02",
      "res_event_number": "69496",
      "product_code": "LPM",
      "pma_numbers": [
        "P890023"
      ],
      "product_description": "Soft Contact Lens",
      "code_info": "Lots # 8246525202 & 8255525096",
      "firm_fei_number": "3002911336",
      "recalling_firm": "Cooper Vision Caribbean Corp.",
      "address_1": "500  Road 584 500 Road 584 Amuelas Industrial Park",
      "city": "Juana Diaz",
      "postal_code": "00795",
      "country": "PR",
      "reason_for_recall": "Portions of the lots may contain units with an incorrect lens axis condition.",
      "root_cause_description": "Process control",
      "action": "This recall is being initiated to the wholesale/distributor and Eye Care Practitioner\nlevel.\nWritten communications will be forwarded to all first level consignees by overnight\nmailin..9. Receipt\" tracking and follow up with consignees will be conducted according to\nthe Effectiveness Check noted below. . - .\nThe 0ff Axis condition is ~onsistent with a situation in which use of, or exposure to, the\nproduct is unlikely to cause adverse health consequences. A user may notice blurred\nvision due to the axis being out of specification but removal of the lens effectively\nreduces/eliminates any impairment. There is currently no indication that use of a lens\nwith an Off Axis condition will create an injury requiring medical intervention. No\npermanent impairment is anticipated with or without medical intervention.\nBased on the analysis \" described in the attached Health Hazard Evaluation,\nCooperVision will initiate a Class Ill recall. As noted by regulation, this classification is\nconsistent with a situation in which use of, or exposure to, the product is unlikely .to\ncause adverse health consequences. Our evaluation of the Off Axis condition indicates\nit is unlikely to cause an adverse health reaction.\nBased on a Class Ill determination, the recall shall be conducted to the Wholesale\nlevel with a planned Effectiveness Check at Level B - 50% of Consignees to be\ncontacted.\nPublic Warning- in light of the low risk and proposed recall classification; a public\nwarning is not warranted at this time.\nDistribution includes:\n\" North America: Canada, USA\n\" Latin America: Argentina, Brasil, Chile, Colombia, Ecuador, Guatemala, Uruguay,\nVenezuela, Mexico\n\" Europe: Belgium, Denmark, Germany, France, Netherlands, Poland, Spain, Sweden,\nSwitzerland\n\" Australia\nReturned lenses will be quarantined from distribution and destroyed as required.\nActions and Dates:\n\" Notify FDA through 806 Form on 10/23/14\n\" Initiate External communications starting 10/28/2014\n\" C",
      "product_quantity": "1170",
      "distribution_pattern": "US Nationwide Distribution.",
      "openfda": {
        "pma_number": [
          "P890012",
          "P820086",
          "P790020",
          "P000030",
          "N17752",
          "P880029",
          "P080011",
          "P890023",
          "P830047",
          "P890049",
          "N16895",
          "N17987",
          "N18033",
          "P850057",
          "P940013",
          "P040045",
          "P790010",
          "P850033",
          "P840044",
          "P780013",
          "P960039",
          "N17679",
          "P850079",
          "P890040",
          "P850058",
          "P780007",
          "P810005",
          "P850078",
          "P220007",
          "P850077",
          "P850039",
          "P830037",
          "P990085",
          "P960022",
          "P010019",
          "P880098",
          "P850068",
          "P980006",
          "P840031",
          "P850072",
          "P780010",
          "P990072",
          "P170035",
          "P820021",
          "P860040"
        ],
        "registration_number": [
          "1123818",
          "3011771819",
          "3012138439",
          "3010890435",
          "3006015326",
          "3008504746",
          "9681121",
          "3030421258",
          "3012167421",
          "3013124682",
          "3006297986",
          "1610287",
          "3006186389",
          "1313525",
          "3012546757",
          "3015430860",
          "3022375855",
          "3009518015",
          "3039590526",
          "3017069344",
          "1067084",
          "3009076545",
          "3036689755",
          "3005395964",
          "3003228982",
          "3015533540",
          "1119279",
          "9614392",
          "3035373204",
          "3006514242",
          "9610731",
          "1057985",
          "8040277",
          "3007064560",
          "2919245",
          "3005724763",
          "3011649033",
          "3015332516",
          "3003365815",
          "2640128",
          "3044853379",
          "3014289638",
          "3010640396",
          "3030261726",
          "3002296055",
          "9610813",
          "3017889743",
          "1053053",
          "3008586477",
          "9617710",
          "1314956"
        ],
        "fei_number": [
          "3011771819",
          "3012138439",
          "3010890435",
          "3006015326",
          "3008504746",
          "3030421258",
          "3012167421",
          "3013124682",
          "3002806417",
          "1610287",
          "3006297986",
          "3002806454",
          "3022375855",
          "3012546757",
          "3002807944",
          "3015430860",
          "3009518015",
          "3039590526",
          "3017069344",
          "3005939549",
          "3009076545",
          "3036689755",
          "3003083595",
          "3005395964",
          "3003228982",
          "3015533540",
          "1119279",
          "1000222023",
          "1000305478",
          "3035373204",
          "3006514242",
          "3002911336",
          "3003495738",
          "3007064560",
          "2919245",
          "3005724763",
          "3011649033",
          "3015332516",
          "3003365815",
          "3044853379",
          "1317628",
          "3014289638",
          "3010640396",
          "3006466212",
          "3030261726",
          "3002296055",
          "3017889743",
          "1053053",
          "3008586477",
          "3002806704",
          "1314956"
        ],
        "device_name": "Lenses, Soft Contact, Extended Wear",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.5925",
        "device_class": "3"
      }
    }
  ]
}