{
  "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,
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  },
  "results": [
    {
      "cfres_id": "86910",
      "product_res_number": "Z-0591-2010",
      "event_date_initiated": "2009-11-19",
      "event_date_posted": "2010-01-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-07-22",
      "res_event_number": "53949",
      "product_code": "HQL",
      "pma_numbers": [
        "P910061"
      ],
      "product_description": "Bausch & Lomb SoFlex SE Foldable Intraocular Lens.\nUPC 4001404, Rx Only, STERILE.\n\nManufactured by:\nBausch & Lomb Incorporated, 21 Park Place Boulevard, Clearwater, FL 33759.\n\nIntraocular lens indicated for primary implantation for visual correction in adult patients where the cataractous lens has been removed by phacoemulsification.  The lens is intended for placement in the capsular bag.",
      "code_info": "Model Number: LI61SE, Lot Number: 4916928.",
      "firm_fei_number": "1317628",
      "recalling_firm": "Bausch & Lomb Inc",
      "address_1": "1400 North Goodman Street",
      "city": "Rochester",
      "state": "NY",
      "postal_code": "14609-3547",
      "additional_info_contact": "David Thomas\n585-338-6000",
      "reason_for_recall": "Bausch & Lomb Incorporated, Rochester, NY is recalling their Silicone L161SE Intraocular Lens Lot 4916928 (23.5D) after receiving three customer complaints for what appears to be opacification of the intraocular lens.  The opacification occurred within one week of implantation.  In each reported case the surgeon explanted the lens.",
      "root_cause_description": "Other",
      "action": "Bausch & Lomb, Inc. notified consignees via phone beginning November 19, 2009 and by follow-up letter dated November 23, 2009.  Titled \"Urgent - Medical Device Recall\", the letter instructed users to discontinue implantation of the affected product and return any unused lenses along with the enclosed acknowledgement form to the firm.\n\nFor further information, contact Bausch & Lomb at 1-585-338-6612.",
      "product_quantity": "85 lenses",
      "distribution_pattern": "Lenses were distributed to one distributor and 35 retailers.  Worldwide Distribution -- Distributed to Canada, Taiwan and throughout the United States.",
      "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",
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          "P790027",
          "P890056",
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          "P890068",
          "P860034",
          "P910058",
          "P080021",
          "P880085",
          "P060022"
        ],
        "registration_number": [
          "1211998",
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        "fei_number": [
          "1211998",
          "2020277",
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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"
      }
    }
  ]
}