{
  "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": 2
    }
  },
  "results": [
    {
      "cfres_id": "105816",
      "product_res_number": "Z-0445-2012",
      "event_date_initiated": "2011-11-14",
      "event_date_posted": "2012-01-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-05-23",
      "res_event_number": "60565",
      "product_code": "NAA",
      "pma_numbers": [
        "P030002"
      ],
      "product_description": "Crystalens Accommodating Posterior Chamber Intraocular Lens, AT-50AO.\n\nCrystalens Accommodating Posterior Chamber Intraocular Lens\nPMA No.: P030002.\n\nThe Crystalens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia.",
      "code_info": "Serial No.: Expiration Date: 11-699865 to 11-699951 01/14/2016 11-699952 to 11-700027 01/14/2016",
      "firm_fei_number": "3004343135",
      "recalling_firm": "Bausch and Lomb, Incorporated",
      "address_1": "30 Enterprise Ste 450 30 Enterprise",
      "address_2": "Ste 450",
      "city": "Aliso Viejo",
      "state": "CA",
      "postal_code": "92656-7115",
      "additional_info_contact": "585-338-8731",
      "reason_for_recall": "Bausch + Lomb voluntary initiated the recall due to a physician complaint of haze on the Crystalens AO\nwhich was visualized using an angled beam from a slit lamp during the post-operative\nexamination.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Bausch + Lomb sent an \"URGENT- MEDICAL DEVICE RECALL\" letter dated November 14, 2011 to all affected customers.  The letter described the product, problem, and actions to be taken by the customers.  The letter instructs customers to remove the affected products from inventory and return the lenses to the firm.  Additionally, a Recall Acknowledgement Form was attached to the letter for customers to complete and return with the affected products.  Contact Bausch + Lomb at 949-521-7895 for questions regarding this recall..",
      "product_quantity": "62 units",
      "distribution_pattern": "Nationwide Distribution",
      "openfda": {
        "pma_number": [
          "P030002"
        ],
        "registration_number": [
          "1119279",
          "1313525",
          "3024715547",
          "3007207818"
        ],
        "fei_number": [
          "1119279",
          "3007207818",
          "3024715547",
          "1317628"
        ],
        "device_name": "Lens, Intraocular, Accommodative",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.3600",
        "device_class": "3"
      }
    }
  ]
}