{
  "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": "42554",
      "product_res_number": "Z-0096-06",
      "event_date_initiated": "2005-10-05",
      "event_date_posted": "2005-10-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-05-23",
      "res_event_number": "33849",
      "product_code": "HQL",
      "pma_numbers": [
        "P960034"
      ],
      "product_description": "CeeOn Heparin Surface\nModified (HSM) PMMA One-Piebe Posterior Chambet- IOLs (Models:722C, 722Y, 811C, 812C and 812CU)",
      "code_info": "CeeOn¿ One-Piece PMMA 722C, 10 lenses  PMMA HSM 722C +19,5 \t8094420508  \t8094430508  \t8094440508 PMMA HSM 722C +22,5 \t8032640508  \t8032830508  \t8032840508  \t8032850508 PMMA HSM 722C +23,0\t8266000508 PMMA HSM 722C +23,5 \t8217920508 PMMA HSM 722C +28,5 \t8221020508  CeeOn¿ One-Piece PMMA 722Y, 2 lenses  PMMA HSM 722Y +29,0 \t8136600508  \t8136610508  CeeOn¿ One-Piece PMMA 811C, 1 lens  PMMA HSM 811C +22,0 \t8054190508  CeeOn¿ One-Piece PMMA 812CU, 4 lenses  PMMA HSM 812CU+17,5 \t8139760508 PMMA HSM 812CU+23,0 \t8156200508  \t8156210508  \t8156220508",
      "firm_fei_number": "3003843509",
      "recalling_firm": "Advanced Medical Optics, Inc.",
      "address_1": "1700 E Saint Andrew Pl",
      "city": "Santa Ana",
      "state": "CA",
      "postal_code": "92705-4933",
      "additional_info_contact": "Sandra F. Selvaggi\n714-247-8656",
      "reason_for_recall": "A small opening (channel or tunnel) in the seal of the\nouter Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.",
      "root_cause_description": "Other",
      "action": "A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.",
      "product_quantity": "45 (4 in US)",
      "distribution_pattern": "Nationwide, Austria, Belgium, Switzerland, Germany, Denmark, France, UK, Guadelope, Hong Kong, Croatia,  \nIndia, Italy, Netherlands, and Vietnam",
      "openfda": {
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          "P880010",
          "P800017",
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          "P830040",
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          "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",
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          "3006723646",
          "3010126268",
          "2011171",
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          "9681121",
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          "2029275",
          "2032098",
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          "1119279",
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          "2529709",
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          "3003304724",
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          "1281950",
          "9612169",
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          "2438659",
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          "3015456951",
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          "9614546",
          "1119421",
          "3008449456",
          "3017636737",
          "1038833",
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        ],
        "fei_number": [
          "1211998",
          "2020277",
          "3006723646",
          "3010126268",
          "2011171",
          "3001659659",
          "3007530141",
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          "3010155661",
          "3002957101",
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          "3013202565",
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          "3002808259",
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        ],
        "k_number": [
          "K842892",
          "K913626",
          "K914311",
          "K842504",
          "K771933"
        ],
        "device_name": "Intraocular Lens",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.3600",
        "device_class": "3"
      }
    }
  ]
}