{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "42556",
      "product_res_number": "Z-0097-06",
      "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": [
        "P880070"
      ],
      "product_description": "CeeOn Heparin SurfaceModifie (HSM) PMMA\nOne-Piece Anterior Chamber IOLs (Model: HSM65)",
      "code_info": "CeeOn¿ One-Piece PMMA HSM65, 2 lenses  PMMA HSM HSM65+22,0 \t 8054720508 8054730508",
      "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": {
        "k_number": [
          "K913626",
          "K842504",
          "K914311",
          "K771933",
          "K842892"
        ],
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          "P100016",
          "P860059",
          "P880085",
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          "P080021",
          "P810032",
          "P040020",
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          "P900048",
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          "P820016",
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          "P800016",
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          "P890068",
          "P870075",
          "P880081",
          "P880072",
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        "registration_number": [
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          "3002957101",
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        ],
        "device_name": "Intraocular Lens",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.3600",
        "device_class": "3"
      }
    }
  ]
}